Community‐based maternal and newborn educational care packages for improving neonatal health and survival in low‐ and middle‐income countries

Zohra S Lassi; Sophie GE Kedzior; Zulfiqar A Bhutta

doi:10.1002/14651858.CD007647.pub2

Paquetes de atención educativa comunitaria para la madre y el recién nacido con objeto de mejorar la salud y la supervivencia neonatal en los países de ingresos bajos y medios

Declaraciones de intereses de los autores

Versión publicada: 05 noviembre 2019 Historial de versiones

https://doi.org/10.1002/14651858.CD007647.pub2

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Resumen

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Antecedentes

En los países de ingresos bajos y medios (PIBM), los servicios de salud son utilizados de forma insuficiente, y varios estudios han informado mejorías en los resultados neonatales después de la educación sanitaria impartida a las madres en los hogares, en las unidades de salud o en los hospitales. Sin embargo, la evaluación de la estrategia de educación sanitaria para administrar atención neonatal, como el asesoramiento individual o grupal a través de grupos de pares o de apoyo, o a cargo de profesionales de la salud, requiere una evaluación rigurosa del diseño y la calidad metodológica, así como una evaluación de la coste‐efectividad, la asequibilidad, la sostenibilidad y la reproducibilidad de los diversos sistemas de salud.

Objetivos

Comparar una estrategia educativa comunitaria en salud versus ninguna estrategia o el enfoque existente de educación sanitaria sobre la atención materna y neonatal en PIBM, impartida a las madres o a los miembros de sus familias específicamente en el ámbito comunitario durante el período prenatal o posnatal, en cuanto a la efectividad para mejorar la salud y la supervivencia neonatal (es decir, la mortalidad neonatal, la morbilidad neonatal, el acceso a la atención sanitaria y el coste).

Métodos de búsqueda

Se utilizó la estrategia de búsqueda estándar del Grupo Cochrane de Neonatología para realizar búsquedas en el Registro Cochrane Central de Ensayos Controlados (CENTRAL; 2017, número 4), en la Cochrane Library, MEDLINE vía PubMed (1966 hasta el 2 de mayo 2017), Embase (1980 hasta el 2 de mayo 2017) y en el Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 hasta el 2 de mayo 2017). También se buscaron ensayos controlados aleatorizados y cuasialeatorizados en las bases de datos de ensayos clínicos, las actas de congresos y las listas de referencias de los artículos recuperados.

Criterios de selección

Ensayos controlados aleatorizados, con asignación al azar por grupos o cuasialeatorizados basados en la comunidad.

Obtención y análisis de los datos

Dos autores de la revisión evaluaron de forma independiente la calidad de los ensayos y extrajeron los datos. Se evaluó la calidad de la evidencia mediante los criterios GRADE y se prepararon tablas de "Resumen de resultados".

Resultados principales

Se incluyeron en esta revisión 33 ensayos originales (informados en 62 artículos separados), que se realizaron en África, América Central y América del Sur, y la mayoría de ellos en Asia, específicamente en la India, Pakistán y Bangladesh. De las 33 intervenciones educativas comunitarias proporcionadas, 16 incluyeron a miembros de la familia en el asesoramiento educativo, con mayor frecuencia a la suegra o al futuro padre. La mayoría de los estudios (n = 14) requirieron asesoramiento individualizado entre un profesional de la salud y una madre, y 12 intervenciones incluyeron asesoramiento grupal para madres y ocasionalmente para miembros de la familia; los siete restantes incorporaron componentes de ambos métodos de asesoramiento.

Los análisis muestran que las intervenciones educativas comunitarias en salud tuvieron un impacto significativo en la reducción de la mortalidad neonatal general (cociente de riesgos [CR] 0,87; intervalo de confianza [IC] del 95%: 0,78 a 0,96; modelo de efectos aleatorios; 26 estudios; n = 553 111; I² = 88%; evidencia de calidad muy baja), la mortalidad neonatal temprana (CR 0,74; IC del 95%: 0,66 a 0,84; modelo de efectos aleatorios; 15 estudios que incluyeron 3 subconjuntos de 3 estudios; n = 321 588; I² = 86%; evidencia de calidad muy baja), la mortalidad neonatal tardía (CR 0,54; IC del 95%: 0,40 a 0,74; modelo de efectos aleatorios; 11 estudios; n = 186 643; I² = 88%; evidencia de calidad muy baja) y la mortalidad perinatal (CR 0,83; IC del 95%: 0,75 a 0,91; modelo de efectos aleatorios; 15 estudios; n = 262 613; I² = 81%; evidencia de calidad muy baja). Además, las intervenciones educativas comunitarias en salud aumentaron la utilización de cualquier atención prenatal (CR 1,16; IC del 95%: 1,11 a 1,22; modelo de efectos aleatorios; 18 estudios; n = 307 528; I² = 96%) y el inicio de la lactancia materna (CR 1,56; IC del 95%: 1,37 a 1,77; modelo de efectos aleatorios; 19 estudios; n = 126 375; I² = 99%). Por el contrario, se encontró que las intervenciones educativas comunitarias en salud no tuvieron un impacto significativo sobre el uso de anticonceptivos modernos (CR 1,10; IC del 95%: 0,86 a 1,41; modelo de efectos aleatorios; 3 estudios; n = 22 237; I² = 80%); la presencia de atención especializada durante el parto (CR 1,09; IC del 95%: 0,94 a 1,25; modelo de efectos aleatorios; 10 estudios; n = 117 870; I² = 97%); la utilización de kits de parto estériles (CR 4,44; IC del 95%: 0,71 a 27,76; modelo de efectos aleatorios; 2 estudios; n = 17 087; I² = 98%); y la búsqueda de atención (CR 1,11; IC del 95%: 0,97 a 1,27; modelo de efectos aleatorios; 7 estudios; n = 46 154; I² = 93%).

El análisis de la coste‐efectividad realizado en siete estudios demostró que la coste‐efectividad de los paquetes de intervención osciló entre 910 USD y 11 975 USD para las vidas salvadas de los recién nacidos y las muertes evitadas de los recién nacidos. En el caso de los años de vida ajustados por discapacidad evitados, los costes oscilaron entre 79 USD y 146 USD; dependiendo de la estrategia de intervención; para el coste por año de vidas perdidas evitadas, la estrategia más efectiva fue la del asesoramiento por pares, y el coste fue de USD 33.

Conclusiones de los autores

Esta revisión ofrece evidencia alentadora sobre el valor de la integración de paquetes de intervenciones con componentes educativos proporcionados por una variedad de trabajadores comunitarios en contextos grupales de países de PIBM, con grupos formados por madres, y educación adicional para los miembros de la familia, para mejorar la supervivencia neonatal, especialmente la supervivencia neonatal temprana y tardía.

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

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Paquetes de atención educativa comunitaria para la madre y el recién nacido con objeto de mejorar la salud y la supervivencia neonatal en los países de ingresos bajos y medios

Pregunta de la revisión

¿Es efectiva la intervención educativa comunitaria en salud para la atención del recién nacido para mejorar la salud y la supervivencia neonatal en los países de ingresos bajos y medios?

Antecedentes

En los países de ingresos bajos y medios (PIBM), la utilización de los servicios de salud es baja y la mortalidad y la morbilidad neonatales son altas. Sin embargo, se han documentado mejorías en los resultados neonatales en varios estudios que administraron intervenciones educativas simples sobre salud. Esta revisión evaluó la efectividad de las estrategias de educación sanitaria impartidas a las madres o a sus familiares en el ámbito comunitario de PIBM. También evaluó el impacto de las estrategias de educación sanitaria sobre la mortalidad neonatal, la morbilidad neonatal, el acceso a la atención sanitaria y el coste.

Características de los estudios

Se llevó a cabo un total de 33 estudios experimentales en África, América Central y América del Sur, con una mayoría de ellos realizados en Asia, específicamente en la India, Pakistán y Bangladesh. De las 33 intervenciones educativas comunitarias, 16 requirieron la participación de miembros de la familia, con mayor frecuencia de la suegra o del futuro padre. La mayoría de los estudios (n = 14) incluyó asesoramiento individualizado entre trabajadores sanitarios de la comunidad y madres, y 12 incluyeron asesoramiento grupal que consistía sobre todo en madres, y ocasionalmente miembros de la familia; los siete restantes tuvieron componentes de asesoramiento individual y grupal.

Resultados clave

Esta revisión halló que las intervenciones educativas comunitarias en salud redujeron significativamente la mortalidad neonatal, la mortalidad neonatal temprana y la mortalidad neonatal tardía, así como la mortalidad perinatal. Estas intervenciones también tuvieron un impacto positivo en la utilización de cualquier atención antes del parto (prenatal), la atención durante el embarazo y la iniciación de la lactancia materna dentro de la hora posterior al parto. La revisión muestra que las intervenciones educativas administradas tanto a las madres como a otros miembros de la familia de forma grupal tuvieron un mayor impacto sobre estos resultados. Las intervenciones educativas administradas durante la atención prenatal fueron más efectivas para reducir las muertes neonatales tempranas, y las administradas durante el período prenatal y posnatal (después del parto) fueron más efectivas para reducir las muertes neonatales tardías y perinatales. Las intervenciones educativas durante el período posnatal fueron más efectivas para mejorar las prácticas de lactancia materna.

Calidad de la evidencia

La calidad de la evidencia es baja para los resultados de la mortalidad neonatal y muy baja para la mortalidad temprana, tardía y perinatal. Este hecho representa cuestiones relacionadas con el sesgo, la inconsistencia (variabilidad no explicada de los resultados) y la imprecisión (variación en los estudios que presentan tanto efectos beneficiosos como perjudiciales de la intervención) de los ensayos controlados aleatorizados incluidos.

Authors' conclusions

Implications for practice

We believe that our review offers some encouraging evidence of the value of community health educational interventions in the form of a package of interventions for a significant decrease in early and late neonatal mortality. Providing educational intervention in both the antenatal and postnatal periods can reduce overall neonatal mortality and perinatal mortality, as well as late neonatal mortality, whereas educational interventions delivered during the antenatal period were most effective for reducing early neonatal mortality. Our review also provides evidence that an educational strategy that includes group counselling for participants was the most successful intervention for reducing neonatal mortality and promoting early initiation of breastfeeding. However, because educational interventions were part of a package of interventions, it is difficult to determine if purely educational interventions would be just as effective; this is an area that requires further investigation, which is a limitation of this review. It is also important to note that the quality of evidence for these findings was frequently of low or very low quality due to concerns of risk of bias, inconsistency, and imprecision. Therefore these findings need to be interpreted critically, and there is not sufficient evidence to determine which strategy (e.g. delivered during ANC or PNC or both) performed in these educational packages is most effective. Results from seven trials awaiting classification will contribute to the evidence base for this intervention in the future.

Implications for research

Despite these findings, this analysis largely derives from trials that were conducted mainly in Asia and Africa, with limited evidence from Central and South America. The interventions utilised a combination of strategies, including promotion of routine antenatal care, counselling for iron folic acid supplementation, and ensuring awareness of mothers and access to appropriate health services throughout pregnancy, as well as home visits to provide education and support from a range of community health workers during and following pregnancy. A broad range of educators were utilised across the trials; most studies utilised community health workers or lady health workers, and educators were frequently working on a volunteer basis, with some trials offering incentives in the form of certificates and merchandise. There is thus a clear need for additional research at an appropriate scale and in the correct settings. Also needed are high‐quality randomised controlled trials that employ stringent methods to ensure quality. Although assessment of cost‐effectiveness was one of the objectives of this review, we found paucity of such data in our included trials and only seven studies that reported the actual cost incurred for providing interventions for saving one life, or for one disability‐adjusted life‐year (DALY) averted. Therefore, cost‐effectiveness is a priority area for research in the future, and researchers should facilitate a cost‐effectiveness meta‐analysis by collecting and reporting cost‐effectiveness data in a standardised format and by specifying which components of the intervention were most cost‐effective when provided in the form of packages. As previously mentioned, the major limitation of this review is that the educational intervention provided by most studies was part of a package of interventions; therefore interventions that are purely education based are required, to determine the true effect of community health education on maternal and neonatal outcomes.

Summary of findings

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Summary of findings for the main comparison. Community health educational interventions compared to control in LMICs

Community health educational interventions compared to control in developing countries
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational interventions Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality	RR 0.87 (0.78 to 0.96)	553111 (26 RCTs)	⊕⊕⊝⊝ Low^a,b	25/26 studies have unsure risk or high risk for more than 1 type of bias, with the most common high risk being performance bias. However because the outcome is mortality, blinding is objective and therefore is unlikely to be affected by blinding of outcome assessment. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality	RR 0.74 (0.66 to 0.84)	321588 (15 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can mainly be attributed to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most of the studies overlap and show the same direction of effect; however there is 1 major outlier that is also in the opposite direction. The statistical measure for heterogeneity is high, suggesting inconsistency. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality	RR 0.54 (0.40 to 0.74)	186643 (11 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable. I² (88%) was considerably large; however most of the confidence intervals overlap, and direction of effect is consistent. The confidence interval is wide; however the sample size is sufficient
Perinatal mortality	RR 0.83 (0.75 to 0.91)	262613 (15 RCTs)	⊕⊝⊝⊝ Very low^b,c	I² (81%) was considerably large; some studies (although with small weighting) support the control, and others support the intervention. Most of the confidence intervals overlap; however some CIs are large. The confidence interval is wide; however the sample size is sufficient
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

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Summary of findings 2. Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs

Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational one‐to‐one and group and both counselling (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ One‐to‐one counselling	RR 0.92 (0.71 to 1.20)	105,735 (8 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	Not all confidence intervals overlap, and there is some inconsistency in the direction of effect. However the study with the greatest confidence interval reported weights of only 0.2%. This was further downgraded by 1 as the confidence interval includes both important benefit or harm and no effect. Most studies had concerns in areas of bias that may have affected the outcome; however those with high risk of performance bias should not have impacted the outcome of neonatal mortality
Neonatal mortality ‐ Group counselling	RR 0.83 (0.74 to 0.92)	211,164 (12 RCTs)	⊕⊕⊝⊝ Low^a,b	Around half of the studies raised concerns in areas of bias that may impact the direction of effect; therefore this was downgraded by one level. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Neonatal mortality ‐ Both group and one‐to‐one counselling	RR 0.90 (0.76 to 1.06)	236,212 (6 RCTs)	⊕⊕⊕⊝ Moderate^b	Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality ‐ Group counselling	RR 0.70 (0.61 to 0.80)	122,151 (9 RCTs)	⊕⊕⊝⊝ Low^a,b	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most studies are consistent in the direction of effect; however not all confidence intervals overlap
Early neonatal mortality ‐ One‐to‐one counselling	RR 1.30 (1.01 to 1.67)	18,747 (1 RCT)	⊕⊕⊝⊝ Low^a,c	There was high risk of bias for selection; however this was a cluster‐randomised trial with a large confidence interval
Early neonatal mortality ‐ Both one‐to‐one and group counselling	RR 0.78 (0.65 to 0.93)	180,690 (5 RCTs)	⊕⊕⊕⊝ Moderate^b	There was considerable heterogeneity (I² = 85%), and not all confidence intervals overlapped
Late neonatal mortality ‐ Group counselling	RR 0.50 (0.31 to 0.81)	118,239 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however these were cluster‐randomised trials, and this is justifiable. There was considerable heterogeneity (I² = 91%), and all studies are consistent in their direction; however not all of them overlap. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Both group and one‐to‐one counselling	RR 0.72 (0.57 to 0.91)	68,404 (4 RCTs)	⊕⊕⊕⊝ Moderate^c	Confidence interval is wide
Perinatal mortality ‐ One‐to‐one counselling	RR 0.88 (0.57 to 1.34)	23,829 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	One of the studies that had greater weighting had considerable risk of bias that may impact the direction of effect Confidence intervals do not overlap, and the direction of effect is inconsistent Confidence interval include both important benefit or harm and no effect
Perinatal mortality ‐ Group counselling	RR 0.85 (0.77 to 0.94)	156,505 (8 RCTs)	⊕⊕⊝⊝ Low^a,b	The 2 heaviest weighted studies have concerns regarding selection bias Most confidence intervals overlap, and only 1 study (that has less weighting) is going in the opposite direction of effect
Perinatal mortality ‐ Both group and one‐to‐one counselling	RR 0.78 (0.67 to 0.90)	82,279 (5 RCTs)	⊕⊕⊝⊝ Low^b,c	The confidence interval is wide; however the sample size is sufficient. Most confidence intervals overlap; however 1 of the studies is inconsistent in its direction of effect (although it is weighted the least)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

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Summary of findings 3. Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs

Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational ANC period and PNC period and both periods (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ Education provided during ANC period only	RR 0.84 (0.64 to 1.09)	47,849 (3 RCTs)	⊕⊝⊝⊝ Very low^a,b	Studies were rated evenly, and the quality of evidence was downgraded as all studies had biases that were of unclear or high risk that may have affected the outcome. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Neonatal mortality ‐ Education provided during PNC period only	RR 1.02 (0.84 to 1.24)	172,882 (3 RCTs)	⊕⊕⊝⊝ Low^b	There is inconsistency in the direction of effect
Neonatal mortality ‐ Education provided in both ANC and PNC periods	RR 0.85 (0.76 to 0.96)	332,380 (20 RCTs)	⊕⊝⊝⊝ Very low^a,b	Because the outcome is mortality, blinding is objective and therefore is unlikely to be affected by blinding of outcome assessment Quality of evidence was downgraded 2 points due to inconsistent direction of effect and because not all confidence intervals overlapped
Early neonatal mortality ‐ Education provided during ANC period only	RR 0.64 (0.43 to 0.95)	33,209 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	Quality assessment was downgraded both both studies had reasonable amounts of bias that may have impacted the effect Heterogeneity is high according to I², and there is consistency in the direction of effect, although the larger study's confidence intervals do not overlap the others Confidence interval shows large spread
Early neonatal mortality ‐ Education provided during PNC period only	RR 1.03 (0.94 to 1.12)	111,529 (1 RCT)	⊕⊕⊕⊝ Moderate^c	The confidence interval includes benefit, harm, and no effect
Early neonatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.76 (0.68 to 0.84)	176,850 (12 RCTs)	⊕⊝⊝⊝ Very low^a,b	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with greatest risk of bias concerns had the smallest weighting. Quality of evidence was downgraded 2 points due to inconsistent direction of effect, and not all confidence intervals overlap
Late neonatal mortality ‐ Education provided during ANC period only	RR 0.87 (0.54 to 1.40)	30,952 (1 RCT)	⊕⊝⊝⊝ Very low^a	This was downgraded by 1 level due to possible selection bias
Late neonatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.52 (0.38 to 0.72)	155,691 (10 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable I² (88%) was considerably large; however most of the confidence intervals overlap and direction of effect is consistent This was downgraded by 1 level, as there was a sufficient number of events; however the confidence interval was wide
Perinatal mortality ‐ Education provided during PNC only	RR 0.89 (0.78 to 1.02)	60,480 (1 RCT)	⊕⊕⊕⊕ High	There were no concerns regarding certainty assessment; however this is for only 1 study
Perinatal mortality ‐ Education provided during ANC period only	RR 0.90 (0.59 to 1.39)	33,513 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b	Quality assessment was downgraded because both studies had reasonable amounts of bias that may have impacted the effect. Heterogeneity is large; direction of effect shows inconsistency, and overlapping of confidence intervals is minimal
Perinatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.81 (0.72 to 0.91)	168,620 (12 RCTs)	⊕⊕⊝⊝ Low^b	Direction of effect shows inconsistency; there is also inconsistency in confidence intervals overlapping each other
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANC: antenatal care; CI: confidence interval; LMICs: low‐ to middle‐income countries; PNC: post‐natal care; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

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Summary of findings 4. Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs

Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational intervention for family members and mothers and for mothers only (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ Intervention given to mothers and family members	RR 0.84 (0.74 to 0.95)	282,817 (13 RCTs)	⊕⊕⊝⊝ Low^a,b	Studies that were weighted the highest had the greatest concerns for risk of bias. Not all confidence intervals from these studies overlap, and the direction of effect shows inconsistency across studies
Neonatal mortality ‐ Intervention given to mothers only	RR 0.90 (0.77 to 1.05)	270294 (13 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	An even split of studies presented with risk of bias that may have impacted the results. The confidence interval includes both important benefit or harm and no effect, but the total number of events appears to be sufficient
Early neonatal mortality ‐ Intervention given to mothers and family members	RR 0.70 (0.56 to 0.87)	99,097 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Heterogeneity is high (I² = 88%) and not all confidence intervals overlap; one study is inconsistent in terms of direction of effect. The confidence interval is wide; however the sample size is sufficient
Early neonatal mortality ‐ Intervention given to mothers only	RR 0.78 (0.68 to 0.90)	222,491 (8 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most of the confidence intervals overlap, a small amount of inconsistency regarding direction of effect is evident. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Intervention given to mothers and family members	RR 0.69 (0.51 to 0.92)	76,388 (4 RCTs)	⊕⊕⊝⊝ Low^b,c	I² (49%) is low; all studies are consistent in direction; however some studies cross the line of no effect. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Intervention given to mothers only	RR 0.50 (0.31 to 0.78)	110,255 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable I² (92%) is considerably large; not all confidence intervals of these studies overlap; however some consistency in the direction of effect is evident The confidence interval is wide; however the sample size is sufficient
Perinatal mortality ‐ Intervention given to mothers and family members	RR 0.83 (0.72 to 0.96)	141,824 (7 RCTs)	⊕⊕⊝⊝ Low^a,b	Several studies with greater weighting were at considerable risk of bias in areas (random sequence generation) that may have impacted the outcome Slight inconsistency in the direction of effect is evident between studies, and wide confidence intervals do not all overlap
Perinatal mortality ‐ Intervention given to mothers only	RR 0.83 (0.72 to 0.96)	120,789 (8 RCTs)	⊕⊕⊝⊝ Low^a,b	Several studies with greater weighting were at considerable risk of bias in areas (random sequence generation) that may have impacted the outcome There is slight inconsistency in the direction of effect between studies, and wide confidence intervals do not all overlap
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

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Summary of findings 5. Community health educational interventions compared to control in LMICs: Sensitivity analysis on primary outcomes

Community health educational interventions compared to control in developing countries in LMICs: sensitivity analysis
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational interventions Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality	RR 0.88 (0.79 to 0.98)	497,258 (22 RCTs)	⊕⊕⊝⊝ Moderate^a	Not all confidence intervals from these studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality	RR 0.71 (0.62 to 0.82)	26,472 (11 RCTs)	⊕⊝⊝⊝ Moderate^a	Most studies overlap and are in the same direction of effect; however there is one major outlier that is also in the opposite direction. The statistical measure for heterogeneity is also high, suggesting inconsistency
Late neonatal mortality	RR 0.51 (0.36 to 0.72)	150,867 (9 RCTs)	⊕⊝⊝⊝ Moderate^a	I² (88%) was considerably large; however most confidence intervals overlap, and there is consistent direction of effect
Perinatal mortality	RR 0.84 (0.75 to 0.94)	262,613 (12 RCTs)	⊕⊝⊝⊝ Moderate^a	I² (81%) is considerably large; some studies (although with small weighting) support the control, and others support the intervention. Most confidence intervals overlap; however some CIs are large
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aInconsistency.

Background

Description of the condition

Globally 2.6 million children die in the first month of life and approximately 7000 newborn deaths occur every day, with about one million dying on the first day and close to one million dying within the next six days of life. Most of these deaths occur in low‐ and middle‐income countries (LMICs) (WHO 2018; UNICEF 2017). Deaths occurring in the neonatal period (aged 0 to 27 days) account for 46% (2.614 million) of all deaths among children younger than five years (UNICEF 2017). Extremely high neonatal mortality rates (over 28 per 1000 live births) are typical of several sub‐Saharan African and South Asian countries (UNICEF 2017); currently 1 in 36 newborns die in sub‐Saharan Africa during the first month of life (UNICEF 2017). The precise contributions of various causes of neonatal death are difficult to ascertain because a vast majority of births and deaths occur in homes and thus are poorly reported and categorised (Black 2010). However, birth asphyxia/intrapartum complications and complications due to preterm birth and infectious causes are recognised as major cause of neonatal death (Black 2010; Lawn 2004; Lawn 2005; UNICEF 2017).

Description of the intervention

In an effort to improve outcomes for both mothers and their newborn infants, the "Mother‐Baby Package" was introduced by the World Health Organization (WHO) in 1994 (WHO 2006a). The Mother‐Baby Package consists of a diverse set of interventions considered essential to maternal and newborn health. These interventions include antenatal registration and care, iron or folate supplementation, tetanus toxoid immunisation, and prevention and management of sexually transmitted infections (STIs) and human immunodeficiency virus (HIV) in endemic areas. They involve treatment for underlying medical conditions such as malaria and hookworm infestation, nutritional advice, ensuring clean delivery, presence of a trained birth attendant at delivery, recognition and management of maternal and neonatal complications, neonatal resuscitation, early and exclusive breastfeeding, and prevention and management of neonatal hypothermia and infections such as ophthalmia neonatorum and cord infection. Implementation and coverage of the "Mother‐Baby Package" vary and the services offered are poorly utilised. Community educational interventions targeting expectant mothers and their family members provide an opportunity to educate the mother and her support network on appropriate care during the antenatal and postnatal periods, especially in populations with minimal access to appropriate antenatal care. Providing mothers with skills and methods to access appropriate care can greatly benefit neonatal and maternal health outcomes. These interventions may be disseminated in homes, at health units, or in hospitals and consist of different counselling strategies from a range of healthcare workers.

In LMICs, almost half of mothers lack adequate antenatal care and home births are extremely common (Benova 2018); however only 13% of women who have birthed at home receive postnatal care within 24 hours (WHO 2018), and in 28 African countries, only 66% of births take place in the presence of a skilled birth attendant (Chukwuma 2017). In many settings, care for mother and baby during the critical first few days after delivery is provided entirely outside the formal healthcare sector. In the least developed regions, contraception prevalence is only 40% (UN 2015a), with the proportion of unmet need for contraception highest among women in sub‐Saharan Africa, at 24% (UN 2015a). Also in the least developed regions, fertility rates (average lifetime number of live births per woman used as current fertility rates) are as high as 4.3 live births per woman (UN 2015), which is especially prevalent in Middle and Western Africa (UN 2015). There is also an urban‐rural gap in contraceptive use in many developing regions. This gap is particularly large in sub‐Saharan Africa, where just 18% of rural women and 31% of urban women are using any method of contraception (UNICEF 2010).

Although reasons for high neonatal mortality rates are multi‐factorial and include shortcomings in supply (such as lack of manpower, poor quality, or dearth of medical supplies and equipment), poor health centre to community linkages, malfunctioning referral systems, non‐existent emergency transportation facilities, and inadequately trained service providers and birth attendants, a major factor is the lack of demand for services provided (Atuoye 2015; Ensor 2004; Lawn 2004; Lawn 2005; Nair 2010; Osrin 2003). This is the result of numerous socioeconomic and cultural factors operating at an individual level and at a collective community level, such as poverty, lack of awareness of services offered, aversion to hospitalisation and formal medical care, lack of awareness of when and how to seek help if desired, and lack of female participation in family decision‐making (Ahmed 2001; Bang 2001; Bhardwaj 1995; Bohren 2014; de Zoysa 1998; Ensor 2004; Riaz 2015).

How the intervention might work

In LMICs, health services may be under‐utilised. Several studies have reported improvements in neonatal outcomes following health education on maternal and newborn care imparted to mothers, in home, at a health unit, or in hospital (Baqui 2008 (a); Pasha 2013; Tripathy 2010). However, the evaluation of any health educational strategy, such as one‐to‐one counselling or group counselling via peer or support groups, through the organisation of men's or women's groups, or delivered by healthcare professionals, requires rigorous assessment of methodological design and quality, as well as assessment of cost‐effectiveness, affordability, sustainability, and reproducibility in diverse health systems.

The "Warmi Project" in rural Bolivia achieved significant reductions in perinatal and neonatal mortality rates (from 11.7% pre‐intervention to 4.4% post‐intervention) through support of women's organisations and community health education (O'Rourke 1998). In three rural districts of Pakistan, local women were trained to deliver primary health care and health education and to facilitate community organisation for health improvement (Barzgar 1997). In a poor urban district of Brazil, significant improvements in maternal knowledge and health behaviour were documented following implementation of the "ProNatal Project" which, among other interventions, provided health education at newly established antenatal clinics and in homes (Emond 2002). One year after initiation, significant reductions in infant mortality and diarrhoea‐related mortality, as well as increased use of contraception, were reported. In Bangalore, India, a one‐to‐one educational session with mothers of children under five years resulted in significant improvements in most aspects of home management of diarrhoea (Mangala 2001). The "Newhints" trial is a cluster‐randomised controlled trial based in Ghana that utilises community‐based surveillance officers to deliver education to improve newborn care practices and care‐seeking during pregnancy and childbirth (Kirkwood 2013). This trial was shown to increase care‐seeking by mothers while reducing the neonatal mortality rate. The "UNEST" cluster‐randomised controlled trial based in Uganda utilised community health workers (CHWs) to provide pregnant women with one‐to‐one counselling to improve newborn practices and showed that the intervention group had a greater proportion of women who initiated breastfeeding within an hour after birth compared to the control group (Waiswa 2015). In Malawi, Africa, the MaiKhanda trial utilised a participatory women's group community intervention and facility quality improvement; 50% of the formed groups developed maternal and neonatal health task forces to enhance antenatal coverage and maternal and neonatal health knowledge, as well as facility delivery (Colbourn 2013). Through this women's group approach, a 22% reduction in neonatal mortality was observed and the facility quality improvement intervention appeared to be most effective in reducing late neonatal deaths.

Why it is important to do this review

This systematic review assessed the effectiveness of community health education on maternal and newborn care for improving neonatal survival in LMICs, and attempted to compare the costs of such strategies. The purpose of this review was to determine whether community health education on maternal and newborn care is an effective and cheap method for reducing neonatal mortality and morbidity, and to identify which strategies resulted in the best neonatal outcomes. A plethora of evidence suggests that community‐based interventions are important for improving healthcare delivery and related outcomes (Lassi 2015; Lassi 2016); however no systematic reviews are currently focusing on targeting mothers and their families with health education to improve neonatal and maternal health outcomes. CHWs and other community facilitators can be at the forefront of interventions that may involve education and health promotion, with some interventions demonstrating that CHWs are able to empower communities to change their health behaviours. Because of the increasing rise in healthcare costs, it has become crucial to focus on developing affordable ways to promote health in community settings. It is therefore important to review and compile recent evidence in the form of randomised controlled trials to determine whether community health education on maternal and newborn care is cost‐effective and has the ability to improve neonatal health and survival.

Objectives

To compare a community health education strategy versus no strategy or the existing approach to health education on maternal and newborn care in LMICs, as imparted to mothers or their family members specifically in community settings during the antenatal and/or postnatal period, in terms of effectiveness for improving neonatal health and survival (i.e. neonatal mortality, neonatal morbidity, access to health care, and cost).

Methods

Criteria for considering studies for this review

Types of studies

Community‐based (home, basic health unit (BHU)† or first‐level health facility‡) randomised controlled, cluster‐randomised, or quasi‐randomised controlled trials. We obtained disaggregated data for neonates from trials conducted on neonates as well as children in older age groups.

†A BHU providing primary level health care is either "a dispensary, health post or Maternal and Child health/Family planning (MCH/FP) clinic which provides basic health services, such as health education, simple laboratory tests and treatment".

‡A first‐level health facility or the first referral level is a "district hospital with around 20 beds, providing inpatient services with staff of one or more physicians and few medical specialists, and equipment necessary to carry out most life‐saving surgical and medical procedures".

Types of participants

Types of participants included the following groups.

Women of reproductive age.
Pregnant women at any period of gestation.
Mothers of neonates (up to 28 days of life).
Their spouses/partners.
Other family members (such as mothers‐in‐law).

All participants resided in LMICs.

Types of interventions

Intervention

Community health education on maternal and newborn care* imparted to mothers or their family members in community settings of LMICs (according to the World Bank list (World Bank 2018)) via:

one‐to one‐counselling;
group counselling (in the form of group sessions);
mass media (radio, television, cellular messages, newspaper, brochures, banners, etc.); we will include only studies in which mass media was introduced as a trial for a certain period or as a pilot before launching at a national level to see clear impacts of this intervention compared to control.
Any combination of the above.

The original protocol described a comparison between one‐to‐one counselling and group counselling; however no included studies compared one‐to‐one versus group counselling.

For this review, maternal and newborn care was defined as an intervention essential to maternal and newborn health such as antenatal care, iron/folic acid supplementation, tetanus toxoid immunisation, prevention and management of STI/HIV in endemic areas, nutritional advice, ensuring clean delivery, presence of a trained birth attendant at delivery, recognition and management of maternal and neonatal complications, neonatal resuscitation, early and exclusive breastfeeding, and prevention and management of neonatal hypothermia, neonatal infections, and immunisation.

We did not include studies with a single intervention such as promotion of breastfeeding or use of family planning methods.

Control

The control did not receive the additional educational intervention or received a conventional level of health education.

Types of outcome measures

Primary outcomes

Neonatal mortality

The number of neonatal deaths from any cause among all live births during the trial period.

Early neonatal mortality: from birth through six completed days of life.
Late neonatal mortality: from seven to 28 completed days of life.

Perinatal mortality

The number of stillbirths and the number of newborn deaths within one week of life among all stillbirths and live births during the trial period.

Secondary outcomes

Neonatal infections
1. Number of neonates diagnosed with infection (as defined by study authors) among all live births during the trial period. Infections included:
  1. sepsis;
  2. pneumonia;
  3. meningitis;
  4. gastroenteritis;
  5. tetanus; or
  6. any combination of the above.
Any antenatal care
1. Number of pregnant women among all pregnant women who were attended for reasons related to pregnancy by skilled health personnel (a doctor, or people with midwifery skills who can manage normal deliveries and diagnose or refer obstetrical complications, or both) at least once during pregnancy. Both trained traditional and untrained traditional birth attendants were excluded (WHO 2006).
Use of any method of contraception
1. Number of women of reproductive age (15 to 49 years) or their spouses who reported that they used any contraceptive method during the trial period (any contraceptive method such as female and male sterilisation, injectable and oral hormones, intrauterine devices, diaphragms, spermicides and condoms, natural family planning, and lactational amenorrhoea) (WHO 2006).
Skilled attendance at delivery
1. Number of births among all live births during the trial period that were attended by skilled health personnel (such as a doctor or a skilled attendant capable of managing normal deliveries and referring obstetrical complications, excluding trained or untrained traditional birth attendants) (WHO 2006).
Delivery attended by unskilled or semi‐skilled birth attendant
1. Number of births among all live births during the trial period that were attended by an unskilled (such as an untrained traditional birth attendant, or a relative) or semi‐skilled birth attendant (such as a trained traditional birth attendant).
Use of clean delivery kit
1. Number of deliveries occurring during the trial period for which a clean delivery kit was used by the birth attendant (typically containing a plastic sheet delivery surface, a clean cutting instrument (a new razor blade), clean ties for the cord, soap for ensuring clean hands of the birth attendant, and instructions) (Beun 2003; PATH 2005).
Care‐seeking
1. Number of mothers among all mothers of neonates who sought or were reported to have sought medical care for their neonate's illness during the trial period.
Use of colostrum
1. Number of women who used colostrum among all women who delivered live born babies during the trial period.
Timely initiation of breastfeeding
1. Number of women who initiated breastfeeding within one hour of birth among all women who delivered live born babies during the trial period.
Mothers' understanding of each of the following "healthy" behaviours, among all women interviewed
1. Ways to prevent neonatal infection (such as handwashing, cord care)
2. Signs of neonatal infection
3. Advantages of breastfeeding
4. Family planning methods
5. Willingness to seek formal medical care for neonatal illness
6. Knowledge of health services offered in the community
Total cost of intervention
1. In US dollars for intervention (including recruiting and training personnel to deliver interventions and conducting sessions) among all recipients of the intervention.
Cost per neonatal life saved
1. Cost in US dollars for each neonatal life saved among all live births during the trial period.

Search methods for identification of studies

We used the criteria and standard methods of Cochrane and Cochrane Neonatal.

Electronic searches

We conducted a comprehensive search including the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library; MEDLINE via PubMed (1 January 2012 to 2 May 2017); Embase (1 January 2012 to 2 May 2017); and the Cumulative Index to Nursing and Allied Health Literatue (CINAHL) (1 January 2012 to 2 May 2017), using the search detailed in Appendix 1. We did not apply language restrictions. This search was run to update searches previously run for the reviews published in October 2010 and October 2012, using the search detailed in Appendix 2.

We searched clinical trials registries for ongoing or recently completed trials (clinicaltrials.gov; the World Health Organization’s International Trials Registry and Platform www.whoint/ictrp/search/en/; and the ISRCTN Registry) on 2 May 2017.

Searching other resources

We also searched the reference lists of any articles selected for inclusion in this review to identify additional relevant articles.

Data collection and analysis

We used the standard review methods of Cochrane and Cochrane Neonatal (Cochrane Handbook for Systematic Reviews of Interventions) (Higgins 2011).

Selection of studies

Two review authors ‐ Zohra Lassi (ZL) and Sophie Kedzior (SK) ‐ independently assessed inclusion of all potential studies identified through the search. We resolved disagreement through discussion, and, if required, we consulted a third review author ‐ Zulfiqar Bhutta (ZB).

Data extraction and management

We designed a form on which to extract data. For eligible studies, two review authors (ZL and SK) independently extracted data using the agreed form. We resolved discrepancies through discussion, or, if required, we consulted a third review author. We entered data into Review Manager software and checked them for accuracy (RevMan 2011). We attempted to contact authors of the original reports to request further details when information regarding any of the above was unclear.

Assessment of risk of bias in included studies

Two review authors (ZL and SK) independently assessed the methodological quality of each included trial using the criteria displayed in Appendix 3.

Measures of treatment effect

We carried out statistical analysis using Review Manager software (RevMan 2011).

Dichotomous data

We presented results as summary risk ratio (RRs) with 95% confidence intervals (CI) for dichotomous data.

Continuous data

We planned to use the mean difference (MD) if outcomes were measured in the same way between trials for continuous data. We used the standardised mean difference (SMD) to combine trials that measure the same outcome but used different methods.

Unit of analysis issues

Cluster‐randomised trials

When trials used clustered‐randomisation, we anticipated that study investigators would have presented their results after appropriately controlling for clustering effects (e.g. variance inflated standard errors, hierarchical linear models). When appropriate controls for clustering were not used, we adjusted for cluster effect using the intracluster coefficient (ICC) from the study similar in context and nature. We included cluster‐randomised/quasi‐randomised trials in the analyses along with individually randomised/quasi‐randomised trials. We incorporated data from cluster‐randomised/quasi‐randomised trials using the generic inverse variance method, in which logarithms of RR estimates were used along with the standard error of the logarithms of RR estimates (Higgins 2011).

Dealing with missing data

We noted levels of attrition for included studies. For all outcomes, we carried out analyses, as far as possible, on an intention‐to‐treat basis, that is, we attempted to include in the analyses all participants randomised to each group. The denominator for each outcome in each trial was the number randomised minus the number of any participants whose outcomes are known to be missing.

Assessment of heterogeneity

We applied tests of heterogeneity between trials, if appropriate, using the I² statistic, and by visual inspection of forest plots. If we identified high levels of heterogeneity among trials and visual inspection of forest plots was suggestive, we explored this by performing pre‐specified subgroup analysis. We pre‐specified the following subgroup analysis to investigate heterogeneity in the primary outcome.

Counselling type: one‐to‐one compared to group counselling, or both.
Neonatal mortality rate at baseline.
Timing of intervention: pre‐conceptual, antenatal versus postnatal.
Who receives intervention: mothers, their spouses, or other family members (such as mothers‐in‐law).
Who provides counselling: support groups or peers, health professionals, traditional birth attendants, village health workers, and so forth.

Assessment of reporting biases

Refer to Appendix 3.

Data synthesis

We carried out statistical analysis using Review Manager software (RevMan 2011). We used fixed‐effect meta‐analysis for combining data when trials were examining the same intervention and the trials' populations and methods were judged sufficiently similar. We used random‐effects meta‐analyses when we suspected clinical or methodological heterogeneity between studies sufficient to suggest that treatment effects may differ between trials. If we identified substantial heterogeneity in a fixed‐effect meta‐analysis, we noted this and repeated the analysis using a random‐effects method.

Quality of evidence

We used the GRADE approach to assess the quality of evidence for the following outcomes: neonatal mortality, early neonatal mortality, late neonatal mortality, and perinatal mortality. Two review authors (SK and ZL) independently assessed the quality of evidence for each of the aforementioned outcomes. Primary outcome data were pooled for randomised controlled trials and evidence was downgraded from "high quality" by one level for serious (or by two for very serious) for study limitations (risk of bias), indirectness of evidence, serious inconsistency, imprecision of effect estimates, or potential publication bias. We used the GRADEpro GDT Guideline Development Tool to create a ‘Summary of findings’ table to report the quality of evidence.

The GRADE approach results in an assessment of the quality of a body of evidence according to one of four grades.

High: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Subgroup analysis and investigation of heterogeneity

We applied tests of heterogeneity between trials, if appropriate, by using the I² statistic and by visually inspecting forest plots. If we identified high levels of heterogeneity among the trials and visual inspection of forest plots was suggestive, we explored this by conducting pre‐specified subgroup analysis. We pre‐specified the following subgroup analysis to investigate heterogeneity in the primary outcome.

Counselling type: one‐to‐one versus group counselling, or both.
Neonatal mortality rate at baseline: 30 or more per 1000 live births versus fewer than 30 per 1000 live births.
Timing of intervention: pre‐conceptional, antenatal versus postnatal.
Who receives intervention: mothers, their spouses, or other family members (such as mothers‐in‐law).
Who provides counselling: support groups or peers, health professionals, traditional birth attendants, village health workers, and so forth.

Sensitivity analysis

We carried out sensitivity analyses to explore the effects of adequate allocation concealment and other 'Risk of bias' components on primary outcomes (Appendix 3).

Results

Description of studies

See Characteristics of included studies, Characteristics of excluded studies, Characteristics of studies awaiting classification, and Characteristics of ongoing studies tables.

Results of the search

We ran multiple comprehensive searches for the full review. The PRISMA diagram includes the completed searches and study selections for both 2012 and 2018 (Figure 1). A total of 178 full‐text papers were reviewed for the systematic review; we classified one as ongoing and eight as awaiting classification. Finally, 33 (reported in 62 separate reports) studies met the eligibility criteria for inclusion. All were published journal articles.

Figure 1

Study flow diagram.

Included studies

All 33 included studies were randomised or quasi‐randomised controlled trials.

Comparison 1

"ANY community health educational interventions versus control" (Analysis 1.1; Analysis 1.2; Analysis 1.3; Analysis 1.4; Analysis 1.5; Analysis 1.6; Analysis 1.7; Analysis 1.8; Analysis 1.9; Analysis 1.10; Analysis 1.11; Analysis 1.12; Analysis 1.13)

Comparison 2

"Community health educational one‐to‐one and group and both counselling (subgroup) versus control" (Analysis 2.1; Analysis 2.2; Analysis 2.3; Analysis 2.4; Analysis 2.5; Analysis 2.6; Analysis 2.7; Analysis 2.8; Analysis 2.9)

One‐to one‐counselling (14 studies; Ayiasi 2016; Bashour 2008; Darmstadt 2010; Degefie 2017; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Magoma 2013; McConnell 2016; Mersal 2013; Penfold 2014; Srinivasan 1995; Waiswa 2015; Wu 2011)
Group counselling (in the form of group sessions) (12 studies; Azad 2010; Baqui 2008 (b); Bhandari 2012; Colbourn 2013; Fottrell 2013; Manandhar 2004; Memon 2015; Midhet 2010; More 2012; Persson 2013; Tripathy 2010; Tripathy 2016)
Any combination of the above (seven studies; Baqui 2008 (a); Bhutta 2008; Bhutta 2011; Kumar 2008; Lewycka 2013; Pasha 2013; Soofi 2017)

Comparison 3

"Community health educational [antenatal care] ANC period and [postnatal care] PNC period and both periods (subgroup) versus control" (Analysis 3.1; Analysis 3.2; Analysis 3.3; Analysis 3.4; Analysis 3.5; Analysis 3.6)

ANC period: three studies (Azad 2010; Midhet 2010; More 2012)
PNC period: four studies (Bashour 2008; Bhandari 2012; McConnell 2016; Pasha 2013)
Both periods: 26 studies (Ayiasi 2016; Baqui 2008 (a); Baqui 2008 (b); Bhutta 2008; Bhutta 2011; Colbourn 2013; Darmstadt 2010; Degefie 2017; Fottrell 2013; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Kumar 2008; Lewycka 2013; Magoma 2013; Manandhar 2004; Memon 2015; Mersal 2013; Penfold 2014; Persson 2013; Soofi 2017; Srinivasan 1995; Tripathy 2010; Tripathy 2016; Waiswa 2015; Wu 2011)

Comparison 4

"Community health educational intervention for family members and mothers and mothers only (subgroup) versus control" (Analysis 4.1; Analysis 4.2; Analysis 4.3; Analysis 4.4; Analysis 4.5; Analysis 4.6; Analysis 4.7; Analysis 4.8; Analysis 4.9)

Family members and mothers: 16 studies (Ayiasi 2016; Azad 2010; Baqui 2008 (a); Bhandari 2012; Bhutta 2011; Darmstadt 2010; Degefie 2017; Fottrell 2013; Ijumba 2015; Kirkwood 2013; Kumar 2008; Magoma 2013; Memon 2015; Midhet 2010; More 2012; Penfold 2014)
Mothers only: 17 studies (Baqui 2008 (b); Bashour 2008; Bhutta 2008; Colbourn 2013; Jokhio 2005; Lewycka 2013; Manandhar 2004; McConnell 2016; Mersal 2013; Pasha 2013; Persson 2013; Soofi 2017; Srinivasan 1995; Tripathy 2010; Tripathy 2016; Waiswa 2015; Wu 2011)

Studies did not classify participants consistently, for example, some studies reported on their population as pregnancies, live births, or mothers; therefore participant numbers are not reported above.

No studies with mass media interventions were identified; therefore the proposed comparison was not performed.

Setting

The studies included in this review spanned across Asia, Africa, and Central/South America. From Asia, seven studies were conducted in India (Baqui 2008 (b); Bhandari 2012; Kumar 2008; More 2012; Srinivasan 1995; Tripathy 2010; Tripathy 2016), six in Pakistan (Bhutta 2008; Bhutta 2011; Jokhio 2005; Memon 2015; Midhet 2010; Soofi 2017), four in Bangladesh (Azad 2010; Baqui 2008 (a); Darmstadt 2010; Fottrell 2013), and one each in Nepal (Manandhar 2004), China (Wu 2011), Vietnam (Persson 2013), and Syria (Bashour 2008). A total of 11 studies were conducted in Africa; of those, two were conducted in each of Malawi (Colbourn 2013; Lewycka 2013), Tanzania (Magoma 2013; Penfold 2014), and Uganda (Ayiasi 2016; Waiswa 2015); and one each in Ethiopia (Degefie 2017), Egypt (Mersal 2013), Ghana (Kirkwood 2013), Kenya (McConnell 2016), and South Africa (Ijumba 2015). One study was a multi‐country trial with sites in India, Pakistan, Kenya, Zambia, Guatemala, and Argentina (Pasha 2013).

Sample size

The studies included in this review reported different measures of sample sizes, including number of pregnant women at enrolment and number of live births at the commencement of the study. Some studies reported both of these measures. A proportion of sample sizes were reported as women of reproductive age (15 to 49 years) (Azad 2010; Baqui 2008 (a); Darmstadt 2010; Degefie 2017; Kirkwood 2013; Manandhar 2004; Tripathy 2016; Waiswa 2015). Some studies utilised estimated population sizes at baseline as their sample size (e.g. unions ‐ Azad 2010).

Twenty one of the included studies reported the number of enrolled pregnant women at the start of the study period, and studied a total of 444,324 pregnancies (Ayiasi 2016; Baqui 2008 (a); Baqui 2008 (b); Bashour 2008; Bhandari 2012; Bhutta 2011; Darmstadt 2010; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Kumar 2008; Lewycka 2013; Magoma 2013; Manandhar 2004; Mersal 2013; Midhet 2010; Pasha 2013; Penfold 2014; Soofi 2017; Srinivasan 1995; Tripathy 2010). Sample sizes ranged from 86 in Mersal 2013 to 134,688 in Pasha 2013. Twenty‐six of the included studies reported number of live births at the end of the study period, with a collected total of 563,562 live births (Azad 2010; Baqui 2008 (a); Bhandari 2012; Bhutta 2008; Bhutta 2011; Colbourn 2013; Darmstadt 2010; Degefie 2017; Fottrell 2013; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Kumar 2008; Lewycka 2013; Manandhar 2004; Memon 2015; Midhet 2010; More 2012; Pasha 2013; Penfold 2014; Persson 2013; Soofi 2017; Tripathy 2010; Tripathy 2016; Waiswa 2015; Wu 2011). Live birth sample sizes ranged from 521 in Penfold 2014 to 109,270 in Pasha 2013.

Interventions

All included studies provided a combination of interventions to promote maternal and newborn care for improving neonatal health and survival. These interventions included promotion of routine antenatal care, tetanus toxoid immunisation, nutrition counselling including iron folic acid supplementation, maternal health education, promotion of institutional deliveries, birth and newborn care preparedness, provision of safe delivery kits, clean delivery practices, referrals for emergency obstetrics care, promotion of early and exclusive breastfeeding, kangaroo mother care, newborn resuscitation, management of neonatal infections, referrals for sick newborns, and postnatal visitation and recognition of neonatal danger signs. The studies described packages of interventions; therefore education often was only a component of the intervention and was used in conjunction with other interventions.

The characteristics of all included studies are provided in the Characteristics of included studies table. We identified some key contextual factors from each study and reported those in Table 1.

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Table 1. Key contextual factors in included studies

Study	Family members included	Women/support group	Education given by	ANC, PNC, or both	Baseline NMR (> or < 30 per 1000) I, C	Counselling type (one‐to‐one counselling/group counselling/both)
Ayiasi 2016	Yes	No	CHWs (Village Health Team)	Yes (both)	NA	One‐to‐one
Azad 2010	Yes (mother‐in‐law)	Yes	Local female peer facilitators	Yes (ANC)	21.6, 26.8	Group
Baqui 2008 (a)	Yes (husband)	No	CHWs	Yes (both)	(46.9, 46.7), 48	Both
Baqui 2008 (b)	No	No	CHWs	Yes (both)	NA	Group
Bashour 2008	No	No	Midwives	Yes (PNC)	NA	One‐to‐one
Bhandari 2012	Yes	Yes	CHWs	Yes (PNC)	32.6, 32.4	Group
Bhutta 2008	No	No	LHWs and TBAs	Yes (both)	110.08, 94.64	Both
Bhutta 2011	Yes (additional family members, husband)	Yes	LHWs and TBAs	Yes (both)	48, 51.3	Both
Colbourn 2013	No	Yes	Volunteer facilitators	Yes (both)	(33.3, 29.4, 24) 31.8	Group
Darmstadt 2010	Yes	No	CHWs	Yes (both)	27.9, 25.2	One‐to‐one
Degefie 2017	Yes	No	CHWs, volunteers	Yes (both)	During days 0 to 27: 35, 33.6	One‐to‐one
Fottrell 2013	Yes (men)	Yes	Facilitators	Yes (both)	38.5 (CI 34.8 to 37.4)	Group
Jokhio 2005	No	No	TBAs, LHWs	Yes (both)	NA ‐ No baseline	One‐to‐one
Kirkwood 2013	Yes	No	CBSVs	Yes (both)	32.3, 32.7	One‐to‐one
Kumar 2008	Yes (mother and father‐in‐law, husband)	No	CHWs	Yes (both)	(64.1, 58.9) 54.2	Both
Lewycka 2013	No	Yes	Volunteer peer counsellors	Yes (both)	Assumed baseline MR (34, 27, 76)	Both
Magoma 2013	Yes (male partner)	No	Care providers	Yes (both)	NA	One‐to‐one
Manandhar 2004	No	Yes	Female facilitators	Yes (both)	25.4, 25.1	Group
McConnell 2016	No	No	CHWs	Yes (PNC)	NA	One‐to‐one
Memon 2015	Yes (father, father‐in‐law, mother‐in law)	Yes	CHWs, LHWs	Yes (both)	26, 39.8	Group
Mersal 2013	No	No	NA	Yes (both)	NA	One‐to‐one
Midhet 2010	Yes (husband)	Yes	Female volunteers	Yes (ANC)	NA	Group
More 2012	Yes (other women in the family)	Yes	Female facilitators (Sakhi)	Yes (ANC)	22.3, 18.6	Group
Pasha 2013	No	Yes	TBAs	Yes (PNC)	23.8, 22.5	Both
Penfold 2014	Yes (father, mothers‐in‐law)	No	Community volunteers	Yes (both)	35, 47	One‐to‐one
Persson 2013	No (only if details of neonatal death were required)	Yes	Volunteers from Women's Union, VHWs	Yes (both)	> 15 for both groups	Group
Soofi 2017	No (male community mobilisers ‐ no specifics on relation)	Yes	LHWs	Yes (both)	43.7, 44.6	Both
Srinivasan 1995	No	No	Female ANMs	Yes (both)	18.7, 15.5, 18	One‐to‐one
Ijumba 2015	Yes (participants' mothers, grandmothers, sisters, husband/boyfriend)	No	CHWs	Yes (both)	NA	One‐to‐one
Tripathy 2010	No	Yes	Facilitators	Yes (both)	61.8, 53.6	Group
Tripathy 2016	No	Yes	ASHAs	Yes (both)	63.4, 51.7	Group
Waiswa 2015	No	No	CHWs	Yes (both)	NA	One‐to‐one
Wu 2011	No (no intervention; for survey, yes if mother was not available)	No	Midwives	Yes (both)	37.9, 30.8	One‐to‐one

ANC: antenatal care.

ANM: auxiliary nurse midwife.

ASHA: accredited social health activist.

C: control.

CBSV: community‐based surveillance volunteer.

CHW: community health worker.

I: intervention.

LHW: Lady Health Worker; local health worker.

NA: not available.

NMR: neonatal mortality rate.

PNC: postnatal care.

TBA: traditional birth attendant.

VHW: village health worker.

Comparisons

The comparison groups in all respective studies received the usual health services provided by the government, non‐governmental organisations, and private providers.

Excluded studies

After reviewing the articles, we excluded 100 studies (consisting of 108 papers) and provided reasons for exclusion in the Characteristics of excluded studies table. We excluded 31 studies because they were not conducted in LMICs (Coombs 1998; Di Napoli 2004; Escobar 2001; Hannula 2008; Hoddinott 2006; Ingram 2004; Ingram 2009; Kafatos 1989; Kafatos 1991; Kools 2005; Lin 2008; MacArthur 2009; Martens 2002; Mottl‐Santiago 2008; Murihead 2006; Petrova 2009; Philipp 2001; Pobocik 2000; Rishel 2005; Rosen 2008; Rossiter 1994; Russell 1999; Ryser 1999; Ryser 2004; Sandy 2009; Schneider 2001; Shaw 1999; Stille 2001; Volpe 2000; Whitelaw 1988; Yun 2010); 22 studies because they were not conducted in community settings (Bolam 1998; Chapman 2004; Coskun 2009; Foreit 1993; Forster 2004; Froozani 1999; Gill 2007; Grossman 2009; Haider 1996; Ickovics 2007; Jang 2008; Johnson 2017; Kadam 2005; Merewood 2003; Nichols 2009; Seema 1997; Serwint 1996; Shinwell 2006; Shrestha 2016; Susin 2008; Svenson 2009; Wong 2007); 20 studies because they were not RCTs or quasi‐RCTs (Agboatwalla 1997; Ahluwalia 2000; Alexandre 2007; Bang 1990; Bang 1999; Bartington 2006; Bland 2008; Boulvain 2004; Carlo 2010; Castrucci 2007; Dennis 2001; Gross 2009; Guise 2003; Moran 2006; Quinn 2005; Raghupathy 1996; Rosato 2006; Syed 2006; Syed 2008; Warren 2010); 13 studies because the intervention was not directly related to maternal and newborn care to improve neonatal survival and health (Ayiasi 2015b; Baqui 2015; Bhandari 2004; Bhutta 2009; Davies‐Abetugbo 1996; Dearden 2002; Flax 2009; Haider 2000; Nabulsi 2014; Rahman 2008; Raj 2016; Rawat 2017; Tylleskär 2011); seven studies because the age of the infant was not appropriate for inclusion in the review (Bhandari 2003; Bhattacharya 1988; Hoare 1999; Hotz 2005; Nair 2017; Sachdeva 1994; Roy 2007); four studies because they had no educational component (Gill 2011; Tshefu 2015; Zaidi 2012; Zaidi 2013;); one study because study authors reported findings only in an abstract, resulting in insufficient information (Bhopal 2017); one study because it included no control arm (Sloan 2008); and one study because it did not report on any of the primary outcomes (Kimani‐Murage 2015).

Risk of bias in included studies

All 33 included studies were randomised (n = 5; Ayiasi 2016; Bashour 2008; Ijumba 2015; McConnell 2016; Mersal 2013), cluster‐randomised (n = 26; Azad 2010; Baqui 2008 (a); Bhandari 2012; Bhutta 2008; Bhutta 2011; Colbourn 2013; Darmstadt 2010; Degefie 2017; Fottrell 2013; Jokhio 2005; Kirkwood 2013; Kumar 2008; Lewycka 2013; Magoma 2013; Manandhar 2004; Midhet 2010; More 2012; Pasha 2013; Penfold 2014; Persson 2013; Soofi 2017; Srinivasan 1995; Tripathy 2010; Tripathy 2016; Waiswa 2015; Wu 2011), or quasi‐experimental studies (n = 2; Baqui 2008 (b); Memon 2015).

Please refer to Figure 2 and Figure 3 for details.

Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

In this review, 29 studies had no issues with allocation concealment, as all clusters were randomised at the start, and studies were considered at low risk. One study had high risk of selection bias due to the quasi‐experimental design (Memon 2015). Three studies provided insufficient data on allocation concealment to permit judgement (Baqui 2008 (b); Mersal 2013; Srinivasan 1995).

Blinding

We noted mixed results for blinding of participants and personnel and considered the majority of studies (n = 17) to be at high risk (Azad 2010; Bashour 2008; Colbourn 2013; Degefie 2017; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Lewycka 2013; Magoma 2013; Manandhar 2004; More 2012; Pasha 2013; Penfold 2014; Persson 2013; Soofi 2017; Tripathy 2010; Wu 2011), with the remainder at unclear or low risk, most often due to the study design (cluster‐randomised). Eight studies were deemed at low risk for performance bias (Ayiasi 2016; Baqui 2008 (a); Baqui 2008 (b); Bhutta 2008; Darmstadt 2010; Fottrell 2013; McConnell 2016; Tripathy 2016), and eight were considered to have unclear risk due to insufficient evidence (Bhandari 2012; Bhutta 2011; Kumar 2008; Memon 2015; Mersal 2013; Midhet 2010; Srinivasan 1995; Waiswa 2015).

Regarding detection bias, information in 19 studies was insufficient to permit any judgement for blinding of outcome assessment (Ayiasi 2016; Azad 2010; Baqui 2008 (a); Baqui 2008 (b); Colbourn 2013; Ijumba 2015; Kirkwood 2013; Lewycka 2013; Manandhar 2004; Memon 2015; Mersal 2013; Midhet 2010; More 2012; Pasha 2013; Penfold 2014; Persson 2013; Srinivasan 1995; Waiswa 2015; Wu 2011). Most remaining studies were considered at low risk (n = 12; Bashour 2008; Bhandari 2012; Bhutta 2008; Bhutta 2011; Darmstadt 2010; Degefie 2017; Fottrell 2013; Kumar 2008; McConnell 2016; Soofi 2017; Tripathy 2010; Tripathy 2016), and two were considered at high risk (Jokhio 2005; Magoma 2013).

Incomplete outcome data

Incomplete data were addressed in all studies except eight, which provided insufficient data to permit any judgment (Baqui 2008 (b); Bhutta 2008; Magoma 2013; Memon 2015; Midhet 2010; Penfold 2014; Persson 2013; Waiswa 2015). Of the remaining 25 studies, 24 were considered low risk (Ayiasi 2016; Azad 2010; Baqui 2008 (b); Bashour 2008; Bhandari 2012; Bhutta 2011; Colbourn 2013; Darmstadt 2010; Degefie 2017; Fottrell 2013; Ijumba 2015; Jokhio 2005; Kirkwood 2013; Kumar 2008; Lewycka 2013; Manandhar 2004; Mersal 2013; More 2012; Pasha 2013; Soofi 2017; Srinivasan 1995; Tripathy 2010; Tripathy 2016; Wu 2011), and one was considered high risk due to a high attrition rate (˜ 43%) (McConnell 2016).

Selective reporting

Twenty‐six studies mentioned results as per stated objectives and appeared to be free of selective reporting. Seven studies presented with unclear risk due to insufficient information to permit any judgement (Baqui 2008 (b); Bashour 2008; Ijumba 2015; Magoma 2013; Mersal 2013; Midhet 2010; Srinivasan 1995). For five of these studies, the insufficient information was related to the study not being a registered trial (Ijumba 2015; Magoma 2013; Mersal 2013; Midhet 2010; Srinivasan 1995).

Other potential sources of bias

Most included studies were deemed free from other biases and therefore at low risk (n = 28; Baqui 2008 (a); Baqui 2008 (b); Bashour 2008; Bhandari 2012; Bhutta 2008; Bhutta 2011; Colbourn 2013; Darmstadt 2010; Degefie 2017; Fottrell 2013; Ijumba 2015; Jokhio 2005; Kumar 2008; Lewycka 2013; Magoma 2013; Manandhar 2004; Memon 2015; Mersal 2013; Midhet 2010; More 2012; Pasha 2013; Penfold 2014; Persson 2013; Soofi 2017; Srinivasan 1995; Tripathy 2010; Tripathy 2016; Waiswa 2015). The five remaining studies were considered at high risk for other sources of bias (Ayiasi 2016; Azad 2010; Kirkwood 2013; McConnell 2016; Wu 2011), such as purposive selection, self‐reporting, and potential cross‐contamination.

Effects of interventions

See: Summary of findings for the main comparison Community health educational interventions compared to control in LMICs; Summary of findings 2 Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs; Summary of findings 3 Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs; Summary of findings 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs; Summary of findings 5 Community health educational interventions compared to control in LMICs: Sensitivity analysis on primary outcomes

Primary outcomes

Neonatal mortality (outcomes 1.1, 2.1, 3.1, and 4.1)

Community health education interventions showed a significant impact on reducing neonatal mortality by 13% (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.78 to 0.96; random‐effects model; 26 studies; n = 553,111; Chi² P < 0.00001; I² = 88%; low‐quality evidence on GRADE) (Analysis 1.1; Figure 4; summary of findings Table for the main comparison). It was determined that this finding was of low quality due to concerns of risk of bias and inconsistency across studies. On sensitivity analysis, community health education interventions showed a significant impact on reducing neonatal mortality by 12% (RR 0.88, 95% CI 0.79 to 0.98; random‐effects model; 22 studies; n = 497,258; Chi² P < 0.00001; I² = 89%; medium‐quality evidence on GRADE) (Analysis 5.1; summary of findings Table 5). After studies with high risk of bias were removed, there was still some inconsistency across studies.

Figure 4

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.1 Neonatal mortality.

On subgroup analysis, we found that studies that provided education on one‐to‐one contact had a non‐significant impact on neonatal mortality (RR 0.92, 95% CI 0.71 to 1.20; random‐effects model; 8 studies; n = 105,735; Chi² P < 0.00001; I² = 93%; very low‐quality evidence on GRADE). The quality of evidence was downgraded to very low due to concerns of risk of bias, inconsistency, and imprecision. Education through group counselling managed to reduce neonatal deaths by 17% (RR 0.83, 95% CI 0.74 to 0.92; random‐effects model; 12 studies; n = 211,164; Chi² P < 0.00001; I² = 93%; low‐quality evidence on GRADE); we considered the evidence to be of low quality due to concerns related to risk of bias and inconsistency. Studies that used both these methods during the trial period for each woman did not significantly reduce neonatal mortality (RR 0.90, 95% CI 0.76 to 1.06; random‐effects model; 6 studies; n = 236,212; Chi² P < 0.00001; I² = 84%; moderate‐quality evidence on GRADE) (Analysis 2.1; Figure 5; summary of findings Table 2). This strategy was determined to have moderate‐quality evidence from six RCTs, and we downgraded it for inconsistency.

Figure 5

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.1 Neonatal mortality.

Similarly, studies that delivered educational interventions during both antenatal and postnatal periods managed to reduce neonatal deaths by 15% (RR 0.85, 95% CI 0.76 to 0.96; random‐effects model; 20 studies; n = 332,380; Chi² = P < 0.0000; I² = 88%; very low‐quality evidence on GRADE) (Analysis 3.1; Figure 6; summary of findings Table 3). However, this finding is of very low quality due to concerns of risk of bias and inconsistency. Education delivered during the antenatal period had no impact (RR 0.84, 95% CI 0.64 to 1.09; random‐effects model; 3 studies; n = 47,849; Chi² P < 0.0001; I² = 87%; very low‐quality evidence on GRADE), and those delivered during the postnatal period had no significant impact on neonatal mortality (RR 1.02, 95% CI 0.84 to 1.24; random‐effects model; 3 studies; n = 172,882; Chi² P = 0.03; I² = 66%; low‐quality evidence on GRADE). Evidence concerning these strategies and this outcome was downgraded due to risk of bias and inconsistency for the antenatal care period and inconsistency for interventions delivered during the postnatal period.

Figure 6

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.1 Neonatal mortality.

Education delivered to both family members and mothers managed to reduce neonatal mortality by 16% (RR 0.84, 95% CI 0.74 to 0.95; random‐effects model; 13 studies; n = 282,817; Chi² P < 0.00001; I² = 82%; low‐quality evidence on GRADE), and interventions provided only to mothers showed no impact on reducing neonatal mortality (RR 0.90, 95% CI 0.77 to 1.05; random‐effects model; 13 studies; n = 270,294; Chi² P < 0.00001; I² = 90%; very low‐quality evidence on GRADE) (Analysis 4.1; Figure 7; summary of findings Table 4). Evidence was downgraded for interventions delivered to both family members and mothers due to concerns of risk of bias and inconsistency, and it was downgraded to very low quality for mothers only due to concerns of risk of bias, inconsistency, and imprecision.

Figure 7

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.1 Neonatal mortality.

Early and late neonatal mortality (outcomes 1.2, 2.2, 3.2, 4.2; 1.3, 2.3, 3.3, and 4.3)

Community health education interventions showed a significant impact on reducing early neonatal deaths by 26% (RR 0.74, 95% CI 0.66 to 0.84; random‐effects model; 15 studies that included 3 subsets from 3 studies; n = 321,588; Chi² P < 0.00001; I² = 86%; very low‐quality evidence on GRADE) (Analysis 1.2; Figure 8; summary of findings Table for the main comparison). It was concluded that the evidence was of very low quality because of concerns for risk of bias, inconsistency, and imprecision. On sensitivity analysis, community health education interventions showed a significant impact on reducing early neonatal mortality by 29% (RR 0.71, 95% CI 0.62 to 0.82; random‐effects model; 11 studies; n = 264,72; Chi² P < 0.00001; I² = 87%; medium‐quality evidence on GRADE) (Analysis 5.2; summary of findings Table 5). After studies with high risk of bias were removed, there was still some inconsistency across studies.

Figure 8

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.2 Early neonatal mortality.

Subgroup analysis showed that group counselling had the most significant effect on early neonatal mortality, with a reduction of 30% (RR 0.70, 95% CI 0.61 to 0.80; random‐effects model; 9 studies; n = 122,151; P < 0.0001; I² = 76%; low‐quality evidence on GRADE), which was considered to be of low quality due to risk of bias and inconsistency. Studies that used both group and one‐to‐one counselling reduced early neonatal mortality by 22% (RR 0.78, 95% CI 0.65 to 0.93; random‐effects model; 5 studies; n = 180,690; Chi² P < 0.00001; I² = 85%; moderate‐quality evidence on GRADE) (Analysis 2.2; Figure 9; summary of findings Table 2), and this evidence was determined to be of moderate quality with some concern for inconsistency. Education delivered during the ANC period reduced early neonatal mortality by 36% (RR 0.64, 95% CI 0.43 to 0.95; random‐effects model; 2 studies; n = 33,209; Chi² P < 0.00001; I² = 93%; very low‐quality evidence on GRADE), and education delivered during both ANC and PNC periods reduced early neonatal mortality by 24% (RR 0.76, 95% CI 0.68 to 0.84; random‐effects model; 12 studies; n = 176,850; Chi² P = 0.0003; I² = 65%; very low‐quality evidence on GRADE) (Analysis 3.2; Figure 10; summary of findings Table 3). However, evidence for interventions during the ANC period or both ANC and PNC periods was of very low quality. For ANC, this was due to risk of bias, inconsistency, and imprecision, whereas for both ANC and PNC, there were concerns about risk of bias and inconsistency. On subgroup analysis, we found that educational sessions that involved both mothers and family members had an impact on reducing early neonatal mortality by 30% (RR 0.70, 95% CI 0.56 to 0.87; random‐effects model; 7 studies; n = 99,097; Chi² P < 0.00001; I² = 88%; very low‐quality evidence on GRADE), whereas counselling involving only mothers reduced neonatal mortality by 22% (RR 0.78, 95% CI 0.68 to 0.90; random‐effects model; 8 studies; n = 222,491; Chi² P < 0.00001; I² = 81%; very low‐quality evidence on GRADE) (Analysis 4.2; Figure 11; summary of findings Table 4). Both of these findings were based on very low‐quality evidence attributed to risk of bias, inconsistency, and imprecision.

Figure 9

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.2 Early neonatal mortality.

Figure 10

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.2 Early neonatal mortality.

Figure 11

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.2 Early neonatal mortality.

Community health education interventions showed a significant impact on reducing late neonatal mortality by 46% (RR 0.54, 95% CI 0.40 to 0.74; random‐effects model; 11 studies; n = 186,643; Chi² P < 0.00001; I² = 88%; very low‐quality evidence) (Analysis 1.3; Figure 12; summary of findings Table for the main comparison), and it was determined that the evidence was of very low quality due to risk of bias, inconsistency, and imprecision. On sensitivity analysis, community health education interventions showed a significant impact on reducing late neonatal mortality by 49% (RR 0.51, 95% CI 0.36 to 0.72; random‐effects model; 9 studies; n = 150,876; Chi² P < 0.00001; I² = 89%; medium‐quality evidence on GRADE) (Analysis 5.3; summary of findings Table 5). After studies with high risk of bias were removed, there was still some inconsistency across studies.

Figure 12

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.3 Late neonatal mortality.

Subgroup analysis showed that educational interventions delivered by group counselling significantly reduced late neonatal mortality by 50% (RR 0.50, 95% CI 0.31 to 0.81; random‐effects model; 7 studies; n = 118,239; Chi² P < 0.00001; I² = 91%; very low‐quality evidence on GRADE), although the evidence was of very low quality due to concerns of risk of bias, inconsistency, and imprecision. The combination of group and one‐to‐one counselling reduced neonatal mortality by 28% (RR 0.72, 95% CI 0.57 to 0.91; random‐effects model; 4 studies; n = 68,404; Chi² P = 0.15; I² = 41%; moderate‐quality evidence on GRADE) (Analysis 2.3; Figure 13; summary of findings Table 2); this finding was based on moderate‐quality evidence, which was downgraded due to imprecision. Educational interventions delivered during both ANC and PNC periods had the most significant impact on reducing late neonatal mortality by 58% (RR 0.52, 95% CI 0.38 to 0.72; random‐effects model; 10 studies; n = 155,691; Chi² P < 0.00001; I² = 88%; very low‐quality evidence on GRADE), whereas education provided during only ANC showed no impact (RR 0.87, 95% CI 0.54 to 1.40; random‐effects model; 1 study; n = 30,952; very low‐quality evidence on GRADE) (Analysis 3.3; Figure 14; summary of findings Table 3). Both interventions delivered during both ANC and PNC, and solely in ANC, yielded evidence that was of very low quality due to risk of bias, inconsistency, and imprecision, and large concerns for risk of bias, respectively. Educational sessions that involved both mothers and family members and only mothers had a significant impact on reducing late neonatal mortality by 31% (RR 0.69, 95% CI 0.51 to 0.92; random‐effects model; 4 studies; n = 76,388; Chi² P = 0.10; I² = 49%; low‐quality evidence on GRADE) and by 50% (RR 0.50, 95% CI 0.31 to 0.78; random‐effects model; 7 studies; n = 110,255; Chi² P < 0.00001; I² = 92%; very low‐quality evidence on GRADE), respectively (Analysis 4.3; Figure 15; summary of findings Table 4). The evidence was considered to be of low and very low quality due to risk of bias, inconsistency, and imprecision.

Figure 13

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.3 Late neonatal mortality.

Figure 14

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.3 Late neonatal mortality.

Figure 15

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.3 Late neonatal mortality.

Perinatal mortality (outcomes 1.4, 2.4, 3.4, and 4.4)

Community health education interventions showed a significant impact on reducing perinatal mortality by 17% (RR 0.83, 95% CI 0.75 to 0.91; random‐effects model; 15 studies; n = 262,613; Chi² P < 0.00001; I² = 81%; very low‐quality evidence on GRADE) (Analysis 1.4; Figure 16; summary of findings Table for the main comparison). This evidence was downgraded to very low quality due to strong concerns for inconsistency and imprecision. On sensitivity analysis, community health education interventions showed a significant impact on reducing perinatal neonatal mortality by 16% (RR 0.84, 95% CI 0.75 to 0.94; random‐effects model; 12 studies; n = 224,107; Chi² P < 0.00001; I² = 83%; medium‐quality evidence on GRADE) (Analysis 5.4; summary of findings Table 5). After studies with high risk of bias were removed, there was still some inconsistency across studies.

Figure 16

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.4 Perinatal mortality.

We conducted a subgroup analysis on the mode of educational strategy. Studies that provided education in the form of group meetings had a significant impact on perinatal death reduction by 15% (RR 0.85, 95% CI 0.77 to 0.94; random‐effects model; 8 studies; n = 156,505; Chi² P = 0.02; I² = 55%; low‐quality evidence on GRADE), whereas educational interventions delivered via one‐to‐one counselling had no impact (RR 0.88, 95% CI 0.57 to 1.34; random‐effects model; 2 studies; n = 23,829; Chi² P < 0.00001; I² = 95%; very low‐quality evidence on GRADE), and those delivered by both group and one‐to‐one counselling yielded perinatal mortality reduction by 22% (RR 0.78, 95% CI 0.67 to 0.90; random‐effects model; 5 studies; n = 82,279; Chi² P = 0.010; I² = 70%; low‐quality evidence on GRADE) (Analysis 2.4; Figure 17; summary of findings Table 2). The evidence for these strategies was determined to be of low or very low quality, which was attributed to concerns surrounding risk of bias, inconsistency, and imprecision.

Figure 17

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.4 Perinatal mortality.

On subgroup analysis, we found that studies that delivered educational intervention during the ANC period had no significant impact on reducing perinatal deaths (RR 0.90, 95% CI 0.59 to 1.39; random‐effects model; 1 study and 1 study with 2 subsets; n = 33,513; Chi² P = 0.01; I² = 78%; very low‐quality evidence on GRADE), and those that delivered interventions during both ANC and PNC periods managed to reduce 19% of the perinatal mortality (RR 0.81, 95% CI 0.72 to 0.91; random‐effects model; 12 studies; n = 168,620; Chi² P < 0.00001; I² = 84%; low‐quality evidence on GRADE) (Analysis 3.4; Figure 18; summary of findings Table 3). The quality of evidence was very low and low due to concerns of risk of bias and inconsistency for ANC, and inconsistency for interventions delivered in both ANC and PNC.

Figure 18

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.4 Perinatal mortality.

Another subgroup analysis was performed to determine the impact of recipients receiving the intervention (family and mothers vs only mothers) on perinatal mortality, with a significant reduction of 17% (RR 0.83, 95% CI 0.72 to 0.96; random‐effects model; 7 studies; n = 141,824; Chi² P = 0.0004; I² = 74%; low‐quality evidence on GRADE; and RR 0.83, 95% CI 0.72 to 0.96; random‐effects model; 8 studies; n = 120,789; Chi² P < 0.00001; I² = 85%; low‐quality evidence on GRADE), respectively (Analysis 4.4; Figure 19; summary of findings Table 4). Both strategies were considered to be of low quality due to concerns with both risk of bias and inconsistency.

Figure 19

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.4 Perinatal mortality.

Secondary outcomes

Any antenatal care, use of contraceptives, use of clean delivery kits (outcomes 1.6, 2.5, 4.5; 1.7; and 1.10)

Community health educational interventions increased utilisation of any antenatal care in pregnant women by 16% (RR 1.16, 95% CI 1.11 to 1.22; random‐effects model; 18 studies; n = 307,528; I² = 96%; Chi² P < 0.00001) (Analysis 1.6; Figure 20). Subgroup analysis comparing one‐to‐one versus group counselling showed a non‐significant impact when implemented separately; however when mothers received both one‐to‐one and group counselling, utilisation of any ANC increased by 21% (RR 1.21, 95% CI 1.07 to 1.37; random‐effects model; 5 studies; n = 51,352; I² = 97%; Chi² P < 0.00001) (Analysis 2.5; Figure 21). On subgroup analysis, no improvement was demonstrated for education provided during ANC (RR 0.99, 95% CI 0.98 to 1.00; random‐effects model; 2 studies; n = 51,305; I² = 0%; Chi² P = 0.38). Subgroup analysis comparing the recipient of education (family members and mothers vs only mothers) showed a significant impact for both methods of 20% (RR 1.20, 95% CI 1.06 to 1.36; random‐effects model; 9 studies; n = 102,886; I² = 98%; Chi² P < 0.00001) and 9% (RR 1.09, 95% CI 1.02 to 1.17; random‐effects model; 9 studies; n = 96,042; I² = 93%; Chi² P < 0.00001), respectively (Analysis 4.5; Figure 22).

Community health educational interventions had no impact on the use of contraceptives (RR 1.10, 95% CI 0.86 to 1.41; random‐effects model; 3 studies; n = 22,237; I² = 80%; Chi² P = 0.0004) (Analysis 1.7; Figure 23); no subgroup analysis was possible. Community health education interventions also did not impact the utilisation of clean delivery kits (RR 4.44, 95% CI 0.71 to 27.76; random‐effects model; 2 studies; n = 17,087; I² = 98%; Chi² P < 0.00001) (Analysis 1.10; Figure 24); no subgroup analysis was possible.

Birth attendance at delivery (outcomes 1.8, 1.9, 2.6, 2.7, and 4.6)

Community health educational interventions did not have any impact on utilisation of skilled birth attendance at delivery (RR 1.09, 95% CI 0.94 to 1.25; random‐effects model; 10 studies; n = 117,870; I² = 97%; Chi² P = 0.00001) (Analysis 1.8; Figure 25), nor did the intervention have an impact on delivery attended by an unskilled or semi‐skilled birth attendant (RR 1.02, 95% CI 0.70 to 1.49; random‐effects model; 3 studies; n = 40,456; I² = 50%; Chi² P = 0.13) (Analysis 1.9; Figure 26). When we performed a subgroup analysis, we found that education received through one‐to‐one counselling, group counselling, or both one‐to‐one and group counselling showed a non‐significant increase for the use of a skilled attendant at delivery (RR 1.09, 95% CI 0.94 to 1.25; random‐effects model; 10 studies; n = 117,870; I² = 97%; Chi² P < 0.00001) (Analysis 2.6; Figure 27). Educational interventions delivered in a group counselling setting and by a combination of one‐to‐one and group counselling did not demonstrate an impact on delivery attended by an unskilled or semi‐skilled birth attendant (RR 1.18, 95% CI 0.64 to 2.19; random‐effects model; 2 studies; n = 21,333; I² = 64%; Chi² P = 0.10; and RR 0.85, 95% CI 0.59 to 1.22; random‐effects model; 1 study; n = 19,123) (Analysis 2.7; Figure 28).

Whether the educational intervention was provided to family members and mothers or only to mothers showed a non‐significant increase for the utilisation of a skilled birth attendant at delivery (RR 1.05, 95% CI 0.93 to 1.18; random‐effects model; 4 studies; n = 58,584; I² = 33%; Chi² P = 0.22; and RR 1.11, 95% CI 0.92 to 1.34; random‐effects model; 6 studies; n = 59,286; I² = 98%; Chi² P < 0.00001), respectively (Analysis 4.6; Figure 29).

Neonatal health care‐seeking (outcomes 1.11, 2.8, 3.5, and 4.7)

Community health interventions had no impact on care‐seeking for neonatal illness (RR 1.11, 95% CI 0.97 to 1.27; random‐effects model; 7 studies; n = 46,154; I² = 93%; Chi² P < 0.00001) (Analysis 1.11; Figure 30). The three subgroup analyses performed (timing of intervention, counselling type, and recipient of intervention) did not show any significant impact of the health education intervention on care‐seeking for neonatal illness (Analysis 2.8; Analysis 3.5; Analysis 4.7; Figure 31; Figure 32; Figure 33).

Neonatal infections (outcome 1.5)

Community health educational interventions demonstrated no impact for reducing the amount of neonatal infection by 12% (RR 0.88, 95% CI 0.72 to 1.08; random‐effects model; 2 studies; n = 42,043; I² = 0%, Chi ² P = 0.46) (Analysis 1.5; Figure 34). No subgroup analysis was performed for this outcome.

Colostrum administration and timely initiation of breastfeeding (outcomes 1.12, 1.13, 2.9, 3.6, and 4.9)

Community health educational interventions managed to increase colostrum administration by 16% (RR 1.16, 95% CI 0.83 to 1.61; random‐effects model; 5 studies; n = 28,631; I² = 100%; Chi² P < 0.00001) (Analysis 1.12; Figure 35). When the educational intervention was received by both family members and mothers, there was a significant increase in colostrum administration by 34% (RR 1.34, 95% CI 1.26 to 1.43; random‐effects model; 2 studies; n = 28,631; I² = 44%; Chi² P = 0.18). The intervention did not show an impact of colostrum administration for the intervention received by only mothers (RR 1.06, 95% CI 0.57 to 1.98; random‐effects model; 3 studies; n = 23,534; I² = 100%; P < 0.00001) (Analysis 4.8; Figure 36).

Timely initiation of breastfeeding was improved by 56% (RR 1.56, 95% CI 1.37 to 1.77; random‐effects model; 19 studies; n = 126,375; I² = 99%, Chi² P < 0.00001) (Analysis 1.13; Figure 20). Subgroup analysis based on mode of delivery of education showed that one‐to‐one and combined one‐to‐one and group counselling increased the timely initiation of breastfeeding by 16% (RR 1.16, 95% CI 1.01 to 1.32; random‐effects model; 5 studies; n = 23,927; I² = 96%; Chi² P < 0.00001) and 63% (RR 1.63, 95% CI 1.39 to 1.92; random‐effects model; 6 studies; n = 44,437; I² = 99%; Chi² P < 0.00001), respectively. The mode of delivery that had the greatest impact was group counselling, with an 80% increase for timely initiation of breastfeeding (RR 1.80, 95% CI 1.25 to 2.58; random‐effects model; 8 studies; n = 58,011; I² = 100%; P < 0.00001) (Analysis 2.9; Figure 21). On subgroup analysis, we found that promotion given during the PNC period increased the timely initiation of breastfeeding three‐fold (RR 3.64, 95% CI 3.38 to 3.93; random‐effects model; 1 study; n = 12,367), whereas trials that promoted breastfeeding education in both ANC and PNC periods managed to increase rates by 47% (RR 1.47, 95% CI 1.32 to 1.65; random‐effects model; 18 studies; n = 114,008; I² = 99%; Chi² P < 0.00001) (Analysis 3.6; Figure 22). The subgroup analysis for recipient(s) of the intervention for family members and mothers and for only mothers showed an improvement in timely initiation of breastfeeding of 56% for both groups (Analysis 4.9; Figure 23).

Figure 20

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.13 Timely initiation of breastfeeding.

Figure 21

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.9 Timely initiation of breastfeeding.

Figure 22

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.6 Timely initiation of breastfeeding.

Figure 23

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.9 Timely initiation of breastfeeding.

Infection‐related neonatal mortality

We found no studies in which association of community health educational interventions was observed for infection‐related neonatal mortality.

Mothers' understanding on "healthy" behaviours

We found no studies that reported mothers' understanding of neonatal danger signs.

Costs of interventions and one life saved

Cost data were reported in seven studies. In Manandhar 2004, cost‐effectiveness analysis was done, and the cost per newborn life saved was USD 3442 (USD 4397 including health‐service strengthening costs) and per life‐year saved was USD 111 (USD 142 including health‐service strengthening costs). The cost per neonatal death averted in Baqui 2008 (a) was USD 2995, including health‐systems strengthening costs. In Tripathy 2010, the incremental cost of the women's group intervention was USD 910 per newborn life saved, increasing to USD 1308 (in 2007 prices) when health‐service strengthening activities were included, and the incremental cost per life‐year saved was USD 33 for the women's group intervention (USD 48 inclusive of health‐service strengthening activities). In Fottrell 2013, the prospective cost per newborn death averted was USD 11974, and the cost per year of life lost averted was USD 394. The cost per year of life lost averted in Lewycka 2013 was USD 144 for women's groups and USD 33 for peer counsellors. Tripathy 2016 reported that the incremental cost per newborn death averted was USD 2545, and for averted disability‐adjusted life‐year (DALY), the cost of the intervention was USD 83. In Colbourn 2013, cost‐effectiveness analysis showed that the costs of community intervention, facility intervention, and combined community and facility interventions were $79, $281, and $146 per DALY averted, respectively.

Discussion

Summary of main results

Evidence from 33 studies contributing data to the primary outcomes of this review shows that intervention packages with community health educational components targeting women and their families provided both antenatally and postnatally reduced neonatal mortality (both early and late) and perinatal mortality, and improved several health behaviours, such as using antenatal care. The impact on contraceptive use and on use of clean delivery kits was less certain, and no studies reported on infection‐related neonatal mortality or mothers' understanding of "healthy" behaviours. The cluster‐randomised and quasi‐randomised controlled trials included in this systematic review provide convincing evidence of the effectiveness of community health educational interventions, particularly those that included both one‐to‐one and group counselling as a method of imparting knowledge and awareness for reducing neonatal and perinatal mortalities. These educational interventions also promoted better utilisation of antenatal care and timely initiation of breastfeeding.

We found a paucity of eligible studies that implemented interventions (generally as birth preparedness and antenatal care (ANC) and postnatal care (PNC) with emphasis on management of neonatal illness). Our meta‐analysis showed a significant reduction in neonatal mortality (13%) and perinatal mortality (17%), as well as a significant reduction in early (26%) and late neonatal mortality (46%), observed as a consequence of implementation of educational interventions. We noted a significant increase in use of any antenatal care (16%), use of colostrum (16%), and timely initiation of breastfeeding (56%).

Subgroup analysis investigating the most appropriate delivery method ‐ one‐to‐one counselling, group counselling, or both ‐ showed that when the educational strategy utilised only group counselling, neonatal mortality was reduced by 17%. Subgroup analysis also demonstrated that group counselling was the most effective method for reducing both early and late neonatal mortality, with reductions of 30% and 50% observed. It was also effective in reducing perinatal mortality by 15%.

In our subgroup analysis, we found that community health education interventions that focused on and promoted awareness related to neonatal health and birth preparedness based on both the antenatal period and the postnatal period reduced neonatal mortality by 15%. For reducing early neonatal mortality, educational interventions provided during the ANC period were most effective (36%), whereas late neonatal mortality interventions provided during both ANC and PNC were most effective (58%). The greatest reductions in perinatal mortality were observed when education was provided during both antenatal and postnatal periods (19%) as opposed to only the antenatal period, which had no significant effect. It was also observed that there were greater reductions in neonatal mortality when mothers were provided with educational interventions during both antenatal and postnatal periods (15%) as opposed to antenatal and postnatal periods separately, as both yielded a non‐significant impact. These results highlight the importance of receiving quality care during and after pregnancy and its impact on neonatal outcomes, and they suggest that the most effective educational interventions should be delivered in both the antenatal period and the postnatal period for the greatest reductions in neonatal and perinatal mortality.

The final subgroup analysis investigated whether the type of recipient who received the intervention ‐ mother, or both mother and family members ‐ impacted the outcomes. It was shown that educational interventions were most effective for reducing neonatal mortality (16%) when received by both mothers and family members. This was also demonstrated for early neonatal mortality with a reduction of 30%, late neonatal mortality with a reduction of 31%, and perinatal mortality with a reduction of 17% when education was provided to both mothers and family members.

Overall completeness and applicability of evidence

Notably, most of the reviewed studies when implemented neglected to document the complete description and characteristics of educators deployed, especially the level and amount of training provided, which could have helped in identifying the importance of these factors and their association with study outcomes. This information would be of great relevance, and additional information on the initial level of educators, their mode of training, and the balance of practical or theoretical sessions would have provided greater assistance to those seeking to understand effects of these factors on educators' performance in community settings. Although the crude impact of educational interventions can be interpreted further, information on contextual factors of educators would have provided the underpinnings needed to recommend the most effective type of training for successful programmes.

It is important to understand that most of the interventions studied in this review were provided in the form of 'packages', and it is therefore difficult to establish the temporality of intervention with outcomes. This means that protective effects cannot be attributed to an individual component of the intervention. For example, antibiotics for neonatal sepsis can be one component of an intervention package delivered by community health workers that has the potential to save lives; however, other components of the package, such as neonatal resuscitation, would have similar effects. Another indicator of expected differences in protective effects from different intervention packages was significant statistical heterogeneity in the pooled data. Statistical heterogeneity depends on difference in magnitude (small or large) and direction of effect (favouring and against). It is, therefore, important to interpret these results carefully.

The types of eligible participants for this review included (among others) pregnant women at any period of gestation and mothers of neonates up to 28 days of life. For the outcome 'neonatal mortality' among all births during the 'trial period', data may include deaths that could have occurred before the educational intervention was administered. These deaths cannot be interpreted as reflecting the effect of the intervention, which is a potential limitation of this intervention type to be studied.

Quality of the evidence

Results were analysed using a random‐effects model due to high heterogeneity between studies; the quality of evidence for neonatal mortality was downgraded by two levels to low quality due to high risk of bias and moderate inconsistency between studies (summary of findings Table for the main comparison). For remaining outcomes (early, late, and perinatal mortality), the quality of evidence for community education interventions was downgraded to very low. Evidence for these outcomes was downgraded due to concerns surrounding risk of bias, inconsistency, and imprecision of included randomised controlled trials. Given the low and very low quality of evidence, the true effect of community‐based education on neonatal mortality (early, late, and perinatal) may be substantially different from the estimate of effect.

In the subgroup analysis for timing of educational interventions, evidence ranged from very low to high quality (summary of findings Table 3). Delivery of education during the postnatal period yielded high‐quality evidence for reducing perinatal mortality; however this GRADE assessment was based on only one study (Bhandari 2012). This is also the case for education provided during the postnatal period, which reduced early neonatal mortality; the GRADE assessment resulted in a moderate‐quality rating, but this finding was based on the results of one study (Pasha 2013).

In the subgroup analysis examining the method of community educational interventions (one‐on‐one vs group counselling), evidence was of very low to moderate quality (summary of findings Table 2). Evidence was downgraded due to high risk of bias, inconsistency of results across studies, and imprecision. For the final subgroup analysis examining recipients of the intervention (family and mother vs only mother), evidence was of very low or low quality (summary of findings Table 4).

It should be noted that for all analyses, none of the evidence met GRADE criteria higher than moderate quality, besides the GRADE assessment for one study that made up the subgroup analysis of interventions during the postnatal period for perinatal mortality (Bhandari 2012), due to concerns related to risk of bias, inconsistency, or imprecision.

Potential biases in the review process

We undertook a systematic, thorough search of the literature to identify all studies that met the inclusion criteria for this review. We are confident that all trials that met the inclusion criteria were included in this review. Study selection and data extraction were done in duplicate and independently, and we reached consensus by discussing any discrepancies. A protocol was published for this review. However, it is important to acknowledge that the studies included in this review included education as one component of a package of interventions; therefore it is possible that the benefits of these interventions are attributed to other non‐educational components.

Agreements and disagreements with other studies or reviews

One systematic review ‐ Bryanton 2010 ‐ was conducted to assess the effects of structured postnatal education delivered by an educator on infant general health and parent‐infant relationships. Review authors concluded that the benefits of educational programmes for participants and their newborns remain unclear, whereas our review showed a significant decrease in neonatal and perinatal mortality with further decreases in early and late neonatal mortality observed, as well as improvement in other neonatal health outcomes with educational interventions. However, the studies included in our review included educational interventions as a component of a package of interventions; therefore this disagreement may be attributed to other components of the packages included in this review. No previous reviews have examined the impact of packages of interventions with an educational component.

Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.1 Neonatal mortality.

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Figure 5

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.1 Neonatal mortality.

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Figure 6

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.1 Neonatal mortality.

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Figure 7

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.1 Neonatal mortality.

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Figure 8

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.2 Early neonatal mortality.

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Figure 9

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.2 Early neonatal mortality.

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Figure 10

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.2 Early neonatal mortality.

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Figure 11

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.2 Early neonatal mortality.

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Figure 12

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.3 Late neonatal mortality.

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Figure 13

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.3 Late neonatal mortality.

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Figure 14

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.3 Late neonatal mortality.

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Figure 15

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.3 Late neonatal mortality.

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Figure 16

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.4 Perinatal mortality.

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Figure 17

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.4 Perinatal mortality.

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Figure 18

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.4 Perinatal mortality.

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Figure 19

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.4 Perinatal mortality.

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Figure 20

Forest plot of comparison: 1 Community health educational interventions versus control, outcome: 1.13 Timely initiation of breastfeeding.

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Figure 21

Forest plot of comparison: 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, outcome: 2.9 Timely initiation of breastfeeding.

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Figure 22

Forest plot of comparison: 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, outcome: 3.6 Timely initiation of breastfeeding.

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Figure 23

Forest plot of comparison: 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, outcome: 4.9 Timely initiation of breastfeeding.

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Analysis 1.1

Comparison 1 Community health educational interventions versus control, Outcome 1 Neonatal mortality.

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Analysis 1.2

Comparison 1 Community health educational interventions versus control, Outcome 2 Early neonatal mortality.

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Analysis 1.3

Comparison 1 Community health educational interventions versus control, Outcome 3 Late neonatal mortality.

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Analysis 1.4

Comparison 1 Community health educational interventions versus control, Outcome 4 Perinatal mortality.

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Analysis 1.5

Comparison 1 Community health educational interventions versus control, Outcome 5 Neonatal infection.

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Analysis 1.6

Comparison 1 Community health educational interventions versus control, Outcome 6 Any antenatal care.

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Analysis 1.7

Comparison 1 Community health educational interventions versus control, Outcome 7 Use of any method of contraception.

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Analysis 1.8

Comparison 1 Community health educational interventions versus control, Outcome 8 Skilled attendance at delivery.

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Analysis 1.9

Comparison 1 Community health educational interventions versus control, Outcome 9 Delivery attended by unskilled or semi‐skilled birth attendant.

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Analysis 1.10

Comparison 1 Community health educational interventions versus control, Outcome 10 Use of clean delivery kit.

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Analysis 1.11

Comparison 1 Community health educational interventions versus control, Outcome 11 Care‐seeking for neonatal illness.

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Analysis 1.12

Comparison 1 Community health educational interventions versus control, Outcome 12 Use of colostrum.

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Analysis 1.13

Comparison 1 Community health educational interventions versus control, Outcome 13 Timely initiation of breastfeeding.

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Analysis 2.1

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 1 Neonatal mortality.

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Analysis 2.2

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 2 Early neonatal mortality.

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Analysis 2.3

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 3 Late neonatal mortality.

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Analysis 2.4

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 4 Perinatal mortality.

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Analysis 2.5

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 5 Any antenatal care.

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Analysis 2.6

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 6 Skilled attendance at delivery.

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Analysis 2.7

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 7 Delivery attended by unskilled or semi‐skilled birth attendant.

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Analysis 2.8

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 8 Care‐seeking for neonatal illness.

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Analysis 2.9

Comparison 2 Community health educational one‐to‐one and group and both counselling (subgroup) versus control, Outcome 9 Timely initiation of breastfeeding.

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Analysis 3.1

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 1 Neonatal mortality.

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Analysis 3.2

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 2 Early neonatal mortality.

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Analysis 3.3

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 3 Late neonatal mortality.

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Analysis 3.4

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 4 Perinatal mortality.

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Analysis 3.5

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 5 Care‐seeking for neonatal illness.

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Analysis 3.6

Comparison 3 Community health educational ANC period and PNC period and both periods (subgroup) versus control, Outcome 6 Timely initiation of breastfeeding.

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Analysis 4.1

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 1 Neonatal mortality.

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Analysis 4.2

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 2 Early neonatal mortality.

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Analysis 4.3

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 3 Late neonatal mortality.

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Analysis 4.4

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 4 Perinatal mortality.

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Analysis 4.5

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 5 Any antenatal care.

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Analysis 4.6

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 6 Skilled attendance at delivery.

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Analysis 4.7

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 7 Care‐seeking for neonatal illness.

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Analysis 4.8

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 8 Use of colostrum.

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Analysis 4.9

Comparison 4 Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control, Outcome 9 Timely initiation of breastfeeding.

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Analysis 5.1

Comparison 5 Sensitivity analysis on primary outcomes, Outcome 1 Neonatal mortality.

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Analysis 5.2

Comparison 5 Sensitivity analysis on primary outcomes, Outcome 2 Early neonatal mortality.

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Analysis 5.3

Comparison 5 Sensitivity analysis on primary outcomes, Outcome 3 Late neonatal mortality.

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Analysis 5.4

Comparison 5 Sensitivity analysis on primary outcomes, Outcome 4 Perinatal mortality.

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Summary of findings for the main comparison. Community health educational interventions compared to control in LMICs

Community health educational interventions compared to control in developing countries
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational interventions Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality	RR 0.87 (0.78 to 0.96)	553111 (26 RCTs)	⊕⊕⊝⊝ Low^a,b	25/26 studies have unsure risk or high risk for more than 1 type of bias, with the most common high risk being performance bias. However because the outcome is mortality, blinding is objective and therefore is unlikely to be affected by blinding of outcome assessment. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality	RR 0.74 (0.66 to 0.84)	321588 (15 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can mainly be attributed to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most of the studies overlap and show the same direction of effect; however there is 1 major outlier that is also in the opposite direction. The statistical measure for heterogeneity is high, suggesting inconsistency. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality	RR 0.54 (0.40 to 0.74)	186643 (11 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable. I² (88%) was considerably large; however most of the confidence intervals overlap, and direction of effect is consistent. The confidence interval is wide; however the sample size is sufficient
Perinatal mortality	RR 0.83 (0.75 to 0.91)	262613 (15 RCTs)	⊕⊝⊝⊝ Very low^b,c	I² (81%) was considerably large; some studies (although with small weighting) support the control, and others support the intervention. Most of the confidence intervals overlap; however some CIs are large. The confidence interval is wide; however the sample size is sufficient
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

Summary of findings for the main comparison. Community health educational interventions compared to control in LMICs

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Summary of findings 2. Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs

Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational one‐to‐one and group and both counselling (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ One‐to‐one counselling	RR 0.92 (0.71 to 1.20)	105,735 (8 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	Not all confidence intervals overlap, and there is some inconsistency in the direction of effect. However the study with the greatest confidence interval reported weights of only 0.2%. This was further downgraded by 1 as the confidence interval includes both important benefit or harm and no effect. Most studies had concerns in areas of bias that may have affected the outcome; however those with high risk of performance bias should not have impacted the outcome of neonatal mortality
Neonatal mortality ‐ Group counselling	RR 0.83 (0.74 to 0.92)	211,164 (12 RCTs)	⊕⊕⊝⊝ Low^a,b	Around half of the studies raised concerns in areas of bias that may impact the direction of effect; therefore this was downgraded by one level. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Neonatal mortality ‐ Both group and one‐to‐one counselling	RR 0.90 (0.76 to 1.06)	236,212 (6 RCTs)	⊕⊕⊕⊝ Moderate^b	Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality ‐ Group counselling	RR 0.70 (0.61 to 0.80)	122,151 (9 RCTs)	⊕⊕⊝⊝ Low^a,b	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most studies are consistent in the direction of effect; however not all confidence intervals overlap
Early neonatal mortality ‐ One‐to‐one counselling	RR 1.30 (1.01 to 1.67)	18,747 (1 RCT)	⊕⊕⊝⊝ Low^a,c	There was high risk of bias for selection; however this was a cluster‐randomised trial with a large confidence interval
Early neonatal mortality ‐ Both one‐to‐one and group counselling	RR 0.78 (0.65 to 0.93)	180,690 (5 RCTs)	⊕⊕⊕⊝ Moderate^b	There was considerable heterogeneity (I² = 85%), and not all confidence intervals overlapped
Late neonatal mortality ‐ Group counselling	RR 0.50 (0.31 to 0.81)	118,239 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however these were cluster‐randomised trials, and this is justifiable. There was considerable heterogeneity (I² = 91%), and all studies are consistent in their direction; however not all of them overlap. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Both group and one‐to‐one counselling	RR 0.72 (0.57 to 0.91)	68,404 (4 RCTs)	⊕⊕⊕⊝ Moderate^c	Confidence interval is wide
Perinatal mortality ‐ One‐to‐one counselling	RR 0.88 (0.57 to 1.34)	23,829 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	One of the studies that had greater weighting had considerable risk of bias that may impact the direction of effect Confidence intervals do not overlap, and the direction of effect is inconsistent Confidence interval include both important benefit or harm and no effect
Perinatal mortality ‐ Group counselling	RR 0.85 (0.77 to 0.94)	156,505 (8 RCTs)	⊕⊕⊝⊝ Low^a,b	The 2 heaviest weighted studies have concerns regarding selection bias Most confidence intervals overlap, and only 1 study (that has less weighting) is going in the opposite direction of effect
Perinatal mortality ‐ Both group and one‐to‐one counselling	RR 0.78 (0.67 to 0.90)	82,279 (5 RCTs)	⊕⊕⊝⊝ Low^b,c	The confidence interval is wide; however the sample size is sufficient. Most confidence intervals overlap; however 1 of the studies is inconsistent in its direction of effect (although it is weighted the least)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

Summary of findings 2. Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs

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Summary of findings 3. Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs

Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational ANC period and PNC period and both periods (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ Education provided during ANC period only	RR 0.84 (0.64 to 1.09)	47,849 (3 RCTs)	⊕⊝⊝⊝ Very low^a,b	Studies were rated evenly, and the quality of evidence was downgraded as all studies had biases that were of unclear or high risk that may have affected the outcome. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Neonatal mortality ‐ Education provided during PNC period only	RR 1.02 (0.84 to 1.24)	172,882 (3 RCTs)	⊕⊕⊝⊝ Low^b	There is inconsistency in the direction of effect
Neonatal mortality ‐ Education provided in both ANC and PNC periods	RR 0.85 (0.76 to 0.96)	332,380 (20 RCTs)	⊕⊝⊝⊝ Very low^a,b	Because the outcome is mortality, blinding is objective and therefore is unlikely to be affected by blinding of outcome assessment Quality of evidence was downgraded 2 points due to inconsistent direction of effect and because not all confidence intervals overlapped
Early neonatal mortality ‐ Education provided during ANC period only	RR 0.64 (0.43 to 0.95)	33,209 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	Quality assessment was downgraded both both studies had reasonable amounts of bias that may have impacted the effect Heterogeneity is high according to I², and there is consistency in the direction of effect, although the larger study's confidence intervals do not overlap the others Confidence interval shows large spread
Early neonatal mortality ‐ Education provided during PNC period only	RR 1.03 (0.94 to 1.12)	111,529 (1 RCT)	⊕⊕⊕⊝ Moderate^c	The confidence interval includes benefit, harm, and no effect
Early neonatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.76 (0.68 to 0.84)	176,850 (12 RCTs)	⊕⊝⊝⊝ Very low^a,b	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with greatest risk of bias concerns had the smallest weighting. Quality of evidence was downgraded 2 points due to inconsistent direction of effect, and not all confidence intervals overlap
Late neonatal mortality ‐ Education provided during ANC period only	RR 0.87 (0.54 to 1.40)	30,952 (1 RCT)	⊕⊝⊝⊝ Very low^a	This was downgraded by 1 level due to possible selection bias
Late neonatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.52 (0.38 to 0.72)	155,691 (10 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable I² (88%) was considerably large; however most of the confidence intervals overlap and direction of effect is consistent This was downgraded by 1 level, as there was a sufficient number of events; however the confidence interval was wide
Perinatal mortality ‐ Education provided during PNC only	RR 0.89 (0.78 to 1.02)	60,480 (1 RCT)	⊕⊕⊕⊕ High	There were no concerns regarding certainty assessment; however this is for only 1 study
Perinatal mortality ‐ Education provided during ANC period only	RR 0.90 (0.59 to 1.39)	33,513 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b	Quality assessment was downgraded because both studies had reasonable amounts of bias that may have impacted the effect. Heterogeneity is large; direction of effect shows inconsistency, and overlapping of confidence intervals is minimal
Perinatal mortality ‐ Education provided during both ANC and PNC periods	RR 0.81 (0.72 to 0.91)	168,620 (12 RCTs)	⊕⊕⊝⊝ Low^b	Direction of effect shows inconsistency; there is also inconsistency in confidence intervals overlapping each other
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ANC: antenatal care; CI: confidence interval; LMICs: low‐ to middle‐income countries; PNC: post‐natal care; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

Summary of findings 3. Community health educational ANC period and PNC period and both periods (subgroup) compared to control in LMICs

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Summary of findings 4. Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs

Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational intervention for family members and mothers and for mothers only (subgroup) Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality ‐ Intervention given to mothers and family members	RR 0.84 (0.74 to 0.95)	282,817 (13 RCTs)	⊕⊕⊝⊝ Low^a,b	Studies that were weighted the highest had the greatest concerns for risk of bias. Not all confidence intervals from these studies overlap, and the direction of effect shows inconsistency across studies
Neonatal mortality ‐ Intervention given to mothers only	RR 0.90 (0.77 to 1.05)	270294 (13 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	An even split of studies presented with risk of bias that may have impacted the results. The confidence interval includes both important benefit or harm and no effect, but the total number of events appears to be sufficient
Early neonatal mortality ‐ Intervention given to mothers and family members	RR 0.70 (0.56 to 0.87)	99,097 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Heterogeneity is high (I² = 88%) and not all confidence intervals overlap; one study is inconsistent in terms of direction of effect. The confidence interval is wide; however the sample size is sufficient
Early neonatal mortality ‐ Intervention given to mothers only	RR 0.78 (0.68 to 0.90)	222,491 (8 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most of the confidence intervals overlap, a small amount of inconsistency regarding direction of effect is evident. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Intervention given to mothers and family members	RR 0.69 (0.51 to 0.92)	76,388 (4 RCTs)	⊕⊕⊝⊝ Low^b,c	I² (49%) is low; all studies are consistent in direction; however some studies cross the line of no effect. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Intervention given to mothers only	RR 0.50 (0.31 to 0.78)	110,255 (7 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	High risk of bias was present for blinding across studies; however studies were cluster‐randomised trials, and this is justifiable I² (92%) is considerably large; not all confidence intervals of these studies overlap; however some consistency in the direction of effect is evident The confidence interval is wide; however the sample size is sufficient
Perinatal mortality ‐ Intervention given to mothers and family members	RR 0.83 (0.72 to 0.96)	141,824 (7 RCTs)	⊕⊕⊝⊝ Low^a,b	Several studies with greater weighting were at considerable risk of bias in areas (random sequence generation) that may have impacted the outcome Slight inconsistency in the direction of effect is evident between studies, and wide confidence intervals do not all overlap
Perinatal mortality ‐ Intervention given to mothers only	RR 0.83 (0.72 to 0.96)	120,789 (8 RCTs)	⊕⊕⊝⊝ Low^a,b	Several studies with greater weighting were at considerable risk of bias in areas (random sequence generation) that may have impacted the outcome There is slight inconsistency in the direction of effect between studies, and wide confidence intervals do not all overlap
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aRisk of bias. ^bInconsistency. ^cImprecision.

Summary of findings 4. Community health educational intervention for family members and mothers and for mothers only (subgroup) compared to control in LMICs

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Summary of findings 5. Community health educational interventions compared to control in LMICs: Sensitivity analysis on primary outcomes

Community health educational interventions compared to control in developing countries in LMICs: sensitivity analysis
Patient or population: developing countries Setting: low‐middle‐income countries, community Intervention: community health educational interventions Comparison: control
Outcomes	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Neonatal mortality	RR 0.88 (0.79 to 0.98)	497,258 (22 RCTs)	⊕⊕⊝⊝ Moderate^a	Not all confidence intervals from these studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality	RR 0.71 (0.62 to 0.82)	26,472 (11 RCTs)	⊕⊝⊝⊝ Moderate^a	Most studies overlap and are in the same direction of effect; however there is one major outlier that is also in the opposite direction. The statistical measure for heterogeneity is also high, suggesting inconsistency
Late neonatal mortality	RR 0.51 (0.36 to 0.72)	150,867 (9 RCTs)	⊕⊝⊝⊝ Moderate^a	I² (88%) was considerably large; however most confidence intervals overlap, and there is consistent direction of effect
Perinatal mortality	RR 0.84 (0.75 to 0.94)	262,613 (12 RCTs)	⊕⊝⊝⊝ Moderate^a	I² (81%) is considerably large; some studies (although with small weighting) support the control, and others support the intervention. Most confidence intervals overlap; however some CIs are large
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aInconsistency.

Summary of findings 5. Community health educational interventions compared to control in LMICs: Sensitivity analysis on primary outcomes

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Table 1. Key contextual factors in included studies

Study	Family members included	Women/support group	Education given by	ANC, PNC, or both	Baseline NMR (> or < 30 per 1000) I, C	Counselling type (one‐to‐one counselling/group counselling/both)
Ayiasi 2016	Yes	No	CHWs (Village Health Team)	Yes (both)	NA	One‐to‐one
Azad 2010	Yes (mother‐in‐law)	Yes	Local female peer facilitators	Yes (ANC)	21.6, 26.8	Group
Baqui 2008 (a)	Yes (husband)	No	CHWs	Yes (both)	(46.9, 46.7), 48	Both
Baqui 2008 (b)	No	No	CHWs	Yes (both)	NA	Group
Bashour 2008	No	No	Midwives	Yes (PNC)	NA	One‐to‐one
Bhandari 2012	Yes	Yes	CHWs	Yes (PNC)	32.6, 32.4	Group
Bhutta 2008	No	No	LHWs and TBAs	Yes (both)	110.08, 94.64	Both
Bhutta 2011	Yes (additional family members, husband)	Yes	LHWs and TBAs	Yes (both)	48, 51.3	Both
Colbourn 2013	No	Yes	Volunteer facilitators	Yes (both)	(33.3, 29.4, 24) 31.8	Group
Darmstadt 2010	Yes	No	CHWs	Yes (both)	27.9, 25.2	One‐to‐one
Degefie 2017	Yes	No	CHWs, volunteers	Yes (both)	During days 0 to 27: 35, 33.6	One‐to‐one
Fottrell 2013	Yes (men)	Yes	Facilitators	Yes (both)	38.5 (CI 34.8 to 37.4)	Group
Jokhio 2005	No	No	TBAs, LHWs	Yes (both)	NA ‐ No baseline	One‐to‐one
Kirkwood 2013	Yes	No	CBSVs	Yes (both)	32.3, 32.7	One‐to‐one
Kumar 2008	Yes (mother and father‐in‐law, husband)	No	CHWs	Yes (both)	(64.1, 58.9) 54.2	Both
Lewycka 2013	No	Yes	Volunteer peer counsellors	Yes (both)	Assumed baseline MR (34, 27, 76)	Both
Magoma 2013	Yes (male partner)	No	Care providers	Yes (both)	NA	One‐to‐one
Manandhar 2004	No	Yes	Female facilitators	Yes (both)	25.4, 25.1	Group
McConnell 2016	No	No	CHWs	Yes (PNC)	NA	One‐to‐one
Memon 2015	Yes (father, father‐in‐law, mother‐in law)	Yes	CHWs, LHWs	Yes (both)	26, 39.8	Group
Mersal 2013	No	No	NA	Yes (both)	NA	One‐to‐one
Midhet 2010	Yes (husband)	Yes	Female volunteers	Yes (ANC)	NA	Group
More 2012	Yes (other women in the family)	Yes	Female facilitators (Sakhi)	Yes (ANC)	22.3, 18.6	Group
Pasha 2013	No	Yes	TBAs	Yes (PNC)	23.8, 22.5	Both
Penfold 2014	Yes (father, mothers‐in‐law)	No	Community volunteers	Yes (both)	35, 47	One‐to‐one
Persson 2013	No (only if details of neonatal death were required)	Yes	Volunteers from Women's Union, VHWs	Yes (both)	> 15 for both groups	Group
Soofi 2017	No (male community mobilisers ‐ no specifics on relation)	Yes	LHWs	Yes (both)	43.7, 44.6	Both
Srinivasan 1995	No	No	Female ANMs	Yes (both)	18.7, 15.5, 18	One‐to‐one
Ijumba 2015	Yes (participants' mothers, grandmothers, sisters, husband/boyfriend)	No	CHWs	Yes (both)	NA	One‐to‐one
Tripathy 2010	No	Yes	Facilitators	Yes (both)	61.8, 53.6	Group
Tripathy 2016	No	Yes	ASHAs	Yes (both)	63.4, 51.7	Group
Waiswa 2015	No	No	CHWs	Yes (both)	NA	One‐to‐one
Wu 2011	No (no intervention; for survey, yes if mother was not available)	No	Midwives	Yes (both)	37.9, 30.8	One‐to‐one
ANC: antenatal care. ANM: auxiliary nurse midwife. ASHA: accredited social health activist. C: control. CBSV: community‐based surveillance volunteer. CHW: community health worker. I: intervention. LHW: Lady Health Worker; local health worker. NA: not available. NMR: neonatal mortality rate. PNC: postnatal care. TBA: traditional birth attendant. VHW: village health worker.

Table 1. Key contextual factors in included studies

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Comparison 1. Community health educational interventions versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neonatal mortality Show forest plot	26	553111	Risk Ratio (Random, 95% CI)	0.87 [0.78, 0.96]

2 Early neonatal mortality Show forest plot	15	321588	Risk Ratio (Random, 95% CI)	0.74 [0.66, 0.84]

3 Late neonatal mortality Show forest plot	11	186643	Risk Ratio (Random, 95% CI)	0.54 [0.40, 0.74]

4 Perinatal mortality Show forest plot	15	262613	Risk Ratio (Random, 95% CI)	0.83 [0.75, 0.91]

5 Neonatal infection Show forest plot	2	42043	Risk Ratio (Random, 95% CI)	0.88 [0.72, 1.08]

6 Any antenatal care Show forest plot	18	307528	Risk Ratio (Random, 95% CI)	1.16 [1.11, 1.22]

6.1 Any ANC	7	65811	Risk Ratio (Random, 95% CI)	1.19 [1.07, 1.33]
6.2 ≥ 1 ANC	5	67050	Risk Ratio (Random, 95% CI)	1.17 [1.04, 1.31]
6.3 ≥ 3 ANCs	4	48738	Risk Ratio (Random, 95% CI)	1.07 [0.85, 1.35]
6.4 ≥ 4 ANCs	8	124701	Risk Ratio (Random, 95% CI)	1.14 [1.01, 1.28]
6.5 > 5 ANCs	1	1228	Risk Ratio (Random, 95% CI)	1.31 [1.16, 1.46]
7 Use of any method of contraception Show forest plot	3	22237	Risk Ratio (Random, 95% CI)	1.10 [0.86, 1.41]

8 Skilled attendance at delivery Show forest plot	10	117870	Risk Ratio (Random, 95% CI)	1.09 [0.94, 1.25]

9 Delivery attended by unskilled or semi‐skilled birth attendant Show forest plot	3	40456	Risk Ratio (Random, 95% CI)	1.02 [0.70, 1.49]

10 Use of clean delivery kit Show forest plot	2	17087	Risk Ratio (Random, 95% CI)	4.44 [0.71, 27.76]

11 Care‐seeking for neonatal illness Show forest plot	7	46154	Risk Ratio (Random, 95% CI)	1.11 [0.97, 1.27]

12 Use of colostrum Show forest plot	5	28631	Risk Ratio (Random, 95% CI)	1.16 [0.83, 1.61]

13 Timely initiation of breastfeeding Show forest plot	19	126375	Risk Ratio (Random, 95% CI)	1.56 [1.37, 1.77]

Comparison 1. Community health educational interventions versus control

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Comparison 2. Community health educational one‐to‐one and group and both counselling (subgroup) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neonatal mortality Show forest plot	26	553111	Risk Ratio (Random, 95% CI)	0.87 [0.78, 0.96]

1.1 One‐to‐one counselling	8	105735	Risk Ratio (Random, 95% CI)	0.92 [0.71, 1.20]
1.2 Group counselling	12	211164	Risk Ratio (Random, 95% CI)	0.83 [0.74, 0.92]
1.3 Both group and one‐to‐one counselling	6	236212	Risk Ratio (Random, 95% CI)	0.90 [0.76, 1.06]
2 Early neonatal mortality Show forest plot	15	321588	Risk Ratio (Random, 95% CI)	0.74 [0.66, 0.84]

2.1 Group counselling	9	122151	Risk Ratio (Random, 95% CI)	0.70 [0.61, 0.80]
2.2 One‐to‐one counselling	1	18747	Risk Ratio (Random, 95% CI)	1.30 [1.01, 1.67]
2.3 Both one‐to‐one and group counselling	5	180690	Risk Ratio (Random, 95% CI)	0.78 [0.65, 0.93]
3 Late neonatal mortality Show forest plot	11	186643	Risk Ratio (Random, 95% CI)	0.54 [0.40, 0.74]

3.1 Group counselling	7	118239	Risk Ratio (Random, 95% CI)	0.50 [0.31, 0.81]
3.2 Both group and one‐to‐one counselling	4	68404	Risk Ratio (Random, 95% CI)	0.72 [0.57, 0.91]
4 Perinatal mortality Show forest plot	15	262613	Risk Ratio (Random, 95% CI)	0.83 [0.75, 0.91]

4.1 One‐to‐one counselling	2	23829	Risk Ratio (Random, 95% CI)	0.88 [0.57, 1.34]
4.2 Group counselling	8	156505	Risk Ratio (Random, 95% CI)	0.85 [0.77, 0.94]
4.3 Both group and one‐to‐one counselling	5	82279	Risk Ratio (Random, 95% CI)	0.78 [0.67, 0.90]
5 Any antenatal care Show forest plot	18	198928	Risk Ratio (Random, 95% CI)	1.15 [1.09, 1.21]

5.1 One‐to‐one counselling	5	29743	Risk Ratio (Random, 95% CI)	1.13 [0.94, 1.35]
5.2 Group counselling	8	117833	Risk Ratio (Random, 95% CI)	1.14 [0.99, 1.31]
5.3 Both one‐to‐one and group counselling	5	51352	Risk Ratio (Random, 95% CI)	1.21 [1.07, 1.37]
6 Skilled attendance at delivery Show forest plot	10	117870	Risk Ratio (Random, 95% CI)	1.09 [0.94, 1.25]

6.1 One‐to‐one counselling	2	2296	Risk Ratio (Random, 95% CI)	1.04 [0.96, 1.12]
6.2 Group counselling	5	93799	Risk Ratio (Random, 95% CI)	1.13 [0.81, 1.59]
6.3 Both group and one‐to‐one counselling	3	21775	Risk Ratio (Random, 95% CI)	1.10 [0.83, 1.44]
7 Delivery attended by unskilled or semi‐skilled birth attendant Show forest plot	3	40456	Risk Ratio (Random, 95% CI)	1.02 [0.70, 1.49]

7.1 Group counselling	2	21333	Risk Ratio (Random, 95% CI)	1.18 [0.64, 2.19]
7.2 Both group and one‐to‐one counselling	1	19123	Risk Ratio (Random, 95% CI)	0.85 [0.59, 1.22]
8 Care‐seeking for neonatal illness Show forest plot	7	46154	Risk Ratio (Random, 95% CI)	1.11 [0.97, 1.27]

8.1 One‐to‐one counselling	2	1006	Risk Ratio (Random, 95% CI)	1.15 [0.81, 1.64]
8.2 Group counselling	5	45148	Risk Ratio (Random, 95% CI)	1.11 [0.87, 1.41]
9 Timely initiation of breastfeeding Show forest plot	19	126375	Risk Ratio (Random, 95% CI)	1.56 [1.37, 1.77]

9.1 One‐to‐one counselling	5	23927	Risk Ratio (Random, 95% CI)	1.16 [1.01, 1.32]
9.2 Group counselling	8	58011	Risk Ratio (Random, 95% CI)	1.80 [1.25, 2.58]
9.3 Both one‐to‐one and group counselling	6	44437	Risk Ratio (Random, 95% CI)	1.63 [1.39, 1.92]

Comparison 2. Community health educational one‐to‐one and group and both counselling (subgroup) versus control

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Comparison 3. Community health educational ANC period and PNC period and both periods (subgroup) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neonatal mortality Show forest plot	26	553111	Risk Ratio (Random, 95% CI)	0.87 [0.78, 0.96]

1.1 Education provided during ANC period only	3	47849	Risk Ratio (Random, 95% CI)	0.84 [0.64, 1.09]
1.2 Education provided during PNC period only	3	172882	Risk Ratio (Random, 95% CI)	1.02 [0.84, 1.24]
1.3 Education provided in both ANC and PNC periods	20	332380	Risk Ratio (Random, 95% CI)	0.85 [0.76, 0.96]
2 Early neonatal mortality Show forest plot	15	321588	Risk Ratio (Random, 95% CI)	0.74 [0.66, 0.84]

2.1 Education provided during ANC period only	2	33209	Risk Ratio (Random, 95% CI)	0.64 [0.43, 0.95]
2.2 Education provided during PNC period only	1	111529	Risk Ratio (Random, 95% CI)	1.03 [0.94, 1.12]
2.3 Education provided during both ANC and PNC periods	12	176850	Risk Ratio (Random, 95% CI)	0.76 [0.68, 0.84]
3 Late neonatal mortality Show forest plot	11	186643	Risk Ratio (Random, 95% CI)	0.54 [0.40, 0.74]

3.1 Education provided during ANC period only	1	30952	Risk Ratio (Random, 95% CI)	0.87 [0.54, 1.40]
3.2 Education provided during both ANC and PNC periods	10	155691	Risk Ratio (Random, 95% CI)	0.52 [0.38, 0.72]
4 Perinatal mortality Show forest plot	15	262613	Risk Ratio (Random, 95% CI)	0.83 [0.75, 0.91]

4.1 Education provided during PNC only	1	60480	Risk Ratio (Random, 95% CI)	0.89 [0.78, 1.02]
4.2 Education provided during ANC period only	2	33513	Risk Ratio (Random, 95% CI)	0.90 [0.59, 1.39]
4.3 Education provided during both ANC and PNC periods	12	168620	Risk Ratio (Random, 95% CI)	0.81 [0.72, 0.91]
5 Care‐seeking for neonatal illness Show forest plot	7	46154	Risk Ratio (Random, 95% CI)	1.11 [0.97, 1.27]

5.1 Education provided during ANC period only	2	15192	Risk Ratio (Random, 95% CI)	0.96 [0.85, 1.09]
5.2 Education provided during both ANC and PNC periods	5	30962	Risk Ratio (Random, 95% CI)	1.14 [0.97, 1.34]
6 Timely initiation of breastfeeding Show forest plot	19	126375	Risk Ratio (Random, 95% CI)	1.56 [1.37, 1.77]

6.1 Education provided during PNC only	1	12367	Risk Ratio (Random, 95% CI)	3.64 [3.38, 3.93]
6.2 Education provided in both ANC and PNC periods	18	114008	Risk Ratio (Random, 95% CI)	1.47 [1.32, 1.65]

Comparison 3. Community health educational ANC period and PNC period and both periods (subgroup) versus control

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Comparison 4. Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neonatal mortality Show forest plot	26	553111	Risk Ratio (Random, 95% CI)	0.87 [0.78, 0.96]

1.1 Intervention given to mothers and family members	13	282817	Risk Ratio (Random, 95% CI)	0.84 [0.74, 0.95]
1.2 Intervention given to mothers only	13	270294	Risk Ratio (Random, 95% CI)	0.90 [0.77, 1.05]
2 Early neonatal mortality Show forest plot	15	321588	Risk Ratio (Random, 95% CI)	0.74 [0.66, 0.84]

2.1 Intervention given to mothers and family members	7	99097	Risk Ratio (Random, 95% CI)	0.70 [0.56, 0.87]
2.2 Intervention given to mothers only	8	222491	Risk Ratio (Random, 95% CI)	0.78 [0.68, 0.90]
3 Late neonatal mortality Show forest plot	11	186643	Risk Ratio (Random, 95% CI)	0.54 [0.40, 0.74]

3.1 Intervention given to mothers and family members	4	76388	Risk Ratio (Random, 95% CI)	0.69 [0.51, 0.92]
3.2 Intervention given to mothers only	7	110255	Risk Ratio (Random, 95% CI)	0.50 [0.31, 0.78]
4 Perinatal mortality Show forest plot	15	262613	Risk Ratio (Random, 95% CI)	0.83 [0.75, 0.91]

4.1 Intervention given to mothers and family members	7	141824	Risk Ratio (Random, 95% CI)	0.83 [0.72, 0.96]
4.2 Intervention given to mothers only	8	120789	Risk Ratio (Random, 95% CI)	0.83 [0.72, 0.96]
5 Any antenatal care Show forest plot	18	198928	Risk Ratio (Random, 95% CI)	1.15 [1.09, 1.21]

5.1 Intervention given to mothers and family members	9	102886	Risk Ratio (Random, 95% CI)	1.20 [1.06, 1.36]
5.2 Intervention given to mothers only	9	96042	Risk Ratio (Random, 95% CI)	1.09 [1.02, 1.17]
6 Skilled attendance at delivery Show forest plot	10	117870	Risk Ratio (Random, 95% CI)	1.09 [0.94, 1.25]

6.1 Intervention given to mothers and family members	4	58584	Risk Ratio (Random, 95% CI)	1.05 [0.93, 1.18]
6.2 Intervention given to mothers only	6	59286	Risk Ratio (Random, 95% CI)	1.11 [0.92, 1.34]
7 Care‐seeking for neonatal illness Show forest plot	7	46154	Risk Ratio (Random, 95% CI)	1.11 [0.97, 1.27]

7.1 Intervention given to mothers and family members	4	16198	Risk Ratio (Random, 95% CI)	1.07 [0.90, 1.27]
7.2 Intervention given to mothers only	3	29956	Risk Ratio (Random, 95% CI)	1.17 [0.84, 1.62]
8 Use of colostrum Show forest plot	5	28631	Risk Ratio (Random, 95% CI)	1.16 [0.83, 1.61]

8.1 Intervention given to mothers and family members	2	5097	Risk Ratio (Random, 95% CI)	1.34 [1.26, 1.43]
8.2 Intervention given to mothers only	3	23534	Risk Ratio (Random, 95% CI)	1.06 [0.57, 1.98]
9 Timely initiation of breastfeeding Show forest plot	19	126375	Risk Ratio (Random, 95% CI)	1.56 [1.37, 1.77]

9.1 Intervention given to mothers and family members	10	47466	Risk Ratio (Random, 95% CI)	1.56 [1.26, 1.94]
9.2 Intervention given to mothers only	9	78909	Risk Ratio (Random, 95% CI)	1.56 [1.30, 1.87]

Comparison 4. Community health educational intervention for family members and mothers and for mothers only (subgroup) versus control

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Comparison 5. Sensitivity analysis on primary outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Neonatal mortality Show forest plot	22	497258	Risk Ratio (Random, 95% CI)	0.88 [0.79, 0.98]

2 Early neonatal mortality Show forest plot	11	264672	Risk Ratio (Random, 95% CI)	0.71 [0.62, 0.82]

3 Late neonatal mortality Show forest plot	9	150876	Risk Ratio (Random, 95% CI)	0.51 [0.36, 0.72]

4 Perinatal mortality Show forest plot	12	224107	Risk Ratio (Random, 95% CI)	0.84 [0.75, 0.94]

Comparison 5. Sensitivity analysis on primary outcomes

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Resumen

Antecedentes

Objetivos

Métodos de búsqueda

Criterios de selección

Obtención y análisis de los datos

Resultados principales

Conclusiones de los autores

PICO

PICO

Population

Intervention

Comparison

Outcome

Resumen en términos sencillos

Paquetes de atención educativa comunitaria para la madre y el recién nacido con objeto de mejorar la salud y la supervivencia neonatal en los países de ingresos bajos y medios

Resumen visual

Authors' conclusions

Implications for practice

Implications for research

Summary of findings

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Intervention

Control

Types of outcome measures

Primary outcomes

Neonatal mortality

Perinatal mortality

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Dichotomous data

Continuous data

Unit of analysis issues

Cluster‐randomised trials

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Quality of evidence

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Results

Description of studies

Results of the search

Included studies

Comparison 1

Comparison 2

Comparison 3

Comparison 4

Setting

Sample size

Interventions

Comparisons

Excluded studies

Risk of bias in included studies

Allocation

Blinding

Incomplete outcome data

Selective reporting

Other potential sources of bias

Effects of interventions