Health system and community level interventions for improving antenatal care coverage and health outcomes

Lawrence Mbuagbaw; Nancy Medley; Andrea J Darzi; Marty Richardson; Kesso Habiba Garga; Pierre Ongolo‐Zogo

doi:10.1002/14651858.CD010994.pub2

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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

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.1 ANC coverage: four or more visits.

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Figure 5

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.2 Pregnancy‐related deaths.

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Figure 6

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.6 Deliveries in a health facility.

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Figure 7

Funnel plot of comparison: 1 One intervention versus no intervention, outcome: 1.13 Perinatal mortality.

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Analysis 1.1

Comparison 1 One intervention versus no intervention, Outcome 1 ANC coverage: four or more visits.

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Analysis 1.2

Comparison 1 One intervention versus no intervention, Outcome 2 Pregnancy‐related deaths.

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Analysis 1.3

Comparison 1 One intervention versus no intervention, Outcome 3 ANC coverage: one or more visits.

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Analysis 1.4

Comparison 1 One intervention versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.

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Analysis 1.5

Comparison 1 One intervention versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.

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Analysis 1.6

Comparison 1 One intervention versus no intervention, Outcome 6 Deliveries in a health facility.

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Analysis 1.8

Comparison 1 One intervention versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.

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Analysis 1.9

Comparison 1 One intervention versus no intervention, Outcome 9 Proportion of women treated for syphilis.

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Analysis 1.10

Comparison 1 One intervention versus no intervention, Outcome 10 Proportion of women with HIV who receive a complete antiretroviral course for prevention of mother‐to‐child transmission of HIV.

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Analysis 1.11

Comparison 1 One intervention versus no intervention, Outcome 11 Preterm labour.

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Analysis 1.12

Comparison 1 One intervention versus no intervention, Outcome 12 Low birthweight.

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Analysis 1.13

Comparison 1 One intervention versus no intervention, Outcome 13 Perinatal mortality.

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Analysis 2.1

Comparison 2 Combination of interventions versus no intervention, Outcome 1 ANC coverage: four or more visits.

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Analysis 2.2

Comparison 2 Combination of interventions versus no intervention, Outcome 2 Pregnancy‐related deaths.

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Analysis 2.3

Comparison 2 Combination of interventions versus no intervention, Outcome 3 ANC coverage: one or more visits.

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Analysis 2.4

Comparison 2 Combination of interventions versus no intervention, Outcome 4 Pregnant women initiating ANC in first trimester.

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Analysis 2.5

Comparison 2 Combination of interventions versus no intervention, Outcome 5 Pregnant women receiving ANC from health professional.

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Analysis 2.6

Comparison 2 Combination of interventions versus no intervention, Outcome 6 Deliveries in a health facility.

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Analysis 2.8

Comparison 2 Combination of interventions versus no intervention, Outcome 8 Proportion of women with tetanus protection at birth.

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Analysis 2.9

Comparison 2 Combination of interventions versus no intervention, Outcome 9 Preterm labour.

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Analysis 2.10

Comparison 2 Combination of interventions versus no intervention, Outcome 10 Low birthweight.

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Analysis 2.11

Comparison 2 Combination of interventions versus no intervention, Outcome 11 Perinatal mortality.

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Analysis 4.1

Comparison 4 Combination of interventions versus one intervention, Outcome 1 ANC coverage: four or more visits.

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Analysis 4.2

Comparison 4 Combination of interventions versus one intervention, Outcome 2 Pregnancy‐related deaths.

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Analysis 4.3

Comparison 4 Combination of interventions versus one intervention, Outcome 3 ANC coverage: one or more visits.

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Analysis 4.4

Comparison 4 Combination of interventions versus one intervention, Outcome 4 Deliveries in a health facility.

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Analysis 4.5

Comparison 4 Combination of interventions versus one intervention, Outcome 5 Perinatal mortality.

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Analysis 4.6

Comparison 4 Combination of interventions versus one intervention, Outcome 6 Proportion of women with tetanus protection at birth.

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Analysis 5.1

Comparison 5 Different combinations of interventions, Outcome 1 ANC coverage: four or more visits.

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Analysis 5.4

Comparison 5 Different combinations of interventions, Outcome 4 Deliveries in a health facility.

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Analysis 6.1

Comparison 6 Subgroup analysis, Outcome 1 Health systems vs Population ANC coverage: four or more visits.

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Analysis 6.2

Comparison 6 Subgroup analysis, Outcome 2 Health systems vs Population Pregnancy‐related deaths.

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Analysis 6.3

Comparison 6 Subgroup analysis, Outcome 3 Country Income Low vs High ANC at least 4 visits.

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Analysis 7.1

Comparison 7 One intervention versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.

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Analysis 8.1

Comparison 8 Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias, Outcome 1 ANC coverage: four or more visits.

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Summary of findings for the main comparison. One intervention versus no intervention

Comparison 1: One intervention versus no intervention
Patient or population: improving antenatal care coverage and health outcomes among pregnant women Setting: Argentina, Bangladesh, Brazil, Cuba, Ghana, Honduras, India, Malawi, Mexico, Mongolia, Nepal, Rwanda, South Africa, Tanzania, UK, Vietnam, Zanzibar, Zimbabwe Intervention: One intervention Comparison: No intervention
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no intervention	Risk with One intervention
ANC coverage: four or more visits	Moderate		Average OR 1.11 (1.01 to 1.22)	45022 (10 RCTs)	⊕⊕⊕⊕ HIGH¹	This is the primary analysis, ICC 0.02.
	529 per 1000	555 per 1000 (531 to 578)
Pregnancy‐related deaths	Moderate		Average OR 0.69 (0.45 to 1.08)	114930 (10 RCTs)	⊕⊕⊝⊝ LOW ^{2 3}
	700 per 1000000	483 per 1000000 (315 to 756)
ANC coverage: one or more visits	Moderate		Average OR 1.68 (1.02 to 2.79)	19281 (6 RCTs)	⊕⊕⊕⊝ MODERATE ⁴
	490 per 1000	617 per 1000 (495 to 728)
Deliveries in a health facility	Moderate		Average OR 1.08 (1.02 to 1.15)	74299 (10 RCTs)	⊕⊕⊕⊕ HIGH
	645 per 1000	662 per 1000 (650 to 676)
Perinatal mortality	Moderate		Average OR 0.96 (0.89 to 1.03)	189164 (15 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 5}
	40 per 1000	38 per 1000 (36 to 41)
Low birthweight	Moderate		Average OR 0.94 (0.82 to 1.06)	27154 (5 RCTs)	⊕⊕⊕⊕ HIGH
	125 per 1000	118 per 1000 (105 to 132)
Intermittent Prophylactic Treatment for malaria	Study population		not pooled	00 (0 study)		No trial included in this review reported this outcome.
	not pooled	not pooled
*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; RR: Risk ratio; OR: Odds ratio. Denominators for the calculation of the absolute comparative effects have been taken from individual trial reports or from Prost 2013. Where different denominators are stated in different reports, we have taken the larger. The median control group risk has been calculated from event and participant raw data, where this was available. If we found no raw event and participant data in published reports, these trials were not included in the calculation of the median control group risk. Both the participant totals and the median control group risk are for illustrative purposes only. In the majority of the trials in this review, the final odds ratio presented will not correspond with raw event and participant data due to adjustments made for the effects of cluster design. We have designated the control risk as moderate because it is based on the median of a wide range of baseline rates in control groups.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Statistical heterogeneity, I² = 52%; we did not downgrade for heterogeneity unless the I² > 60%. ² Downgraded one level due to serious risk of bias. Most weight from trials with design limitations (‐1). ³ Downgraded one level due to serious imprecision. Wide confidence interval crossing the line of no effect (‐1). ⁴ Downgraded one level due to serious inconsistency. Statistical heterogeneity, I²= 76% (‐1). ⁵ Statistical heterogeneity, I²= 58%; we did not downgrade for heterogeneity unless the I² > 60%.

Summary of findings for the main comparison. One intervention versus no intervention

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Summary of findings 2. Combination of interventions versus no intervention

Comparison 2: Combination of interventions versus no intervention
Patient or population: improving antenatal care coverage and health outcomes among pregnant women Setting: Eastern China, Honduras, India, Laos, Malawi, Pakistan, South Africa, USA Intervention: Combination of interventions Comparison: No intervention
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no intervention	Risk with Combination of interventions
ANC coverage: four or more visits	Moderate		Average OR 1.48 (0.99 to 2.21)	7840 (6 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3}	This is the primary analysis, ICC 0.02.
	430 per 1000	528 per 1000 (428 to 625)
Pregnancy‐related deaths	Moderate		Average OR 0.70 (0.39 to 1.26)	13756 (3 RCTs)	⊕⊕⊕⊝ MODERATE ³
	600 per 100000	421 per 100000 (235 to 755)
ANC coverage: one or more visits	Moderate		Average OR 1.79 (1.47 to 2.17)	12426 (5 RCTs)	⊕⊕⊕⊝ MODERATE ³
	580 per 1000	712 per 1000 (670 to 750)
Deliveries in a health facility	Moderate		Average 1.53 (0.96 to 2.43)	12314 (5 RCTs)	⊕⊕⊕⊝ MODERATE ³
	165 per 1000	252 per 1000 (158 to 401)
Perinatal mortality	Moderate		Average 0.74 (0.57 to 0.95)	39130 (5 RCTs)	⊕⊕⊕⊝ MODERATE ⁴
	90 per 1000	67 per 1000 (51 to 58)
Low birthweight	Moderate		Average 0.61 (0.46 to 0.80)	2084 (2 RCTs)	⊕⊕⊕⊝ MODERATE ¹
	165 per 1000	101 per 1000 (76 to 132)
Intermittent Prophylactic Treatment for malaria	Study population		not pooled	00 (0 study)		No trial eligible for this comparison reported this outcome
	not pooled	not pooled
*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; RR: Risk ratio; OR: Odds ratio. Denominators for the calculation of the absolute comparative effects have been taken from individual trial reports or from Prost 2013. Where different denominators are stated in different reports, we have taken the larger. The median control group risk has been calculated from event and participant raw data, where this was available. If we found no raw event and participant data in published reports, these trials were not included in the calculation of the median control group risk. Both the participant totals and the median control group risk are for illustrative purposes only. In the majority of the trials in this review, the final odds ratio presented will not correspond with raw event and participant data due to adjustments made for the effects of cluster design. We have designated the control risk as moderate because it is based on the median of a wide range of baseline rates in control groups.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Most weight from trials with design limitations (‐1). ² Statistical heterogeneity, I² = 48% ; we did not downgrade for heterogeneity unless the I² > 60%. ³ Wide confidence interval crossing the line of no effect (‐1). ⁴ Statistical heterogeneity, I² = 83% (‐1).

Summary of findings 2. Combination of interventions versus no intervention

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Table 1. Primary outcome 1.1 Proportion of women with at least 4 ANC visits

Study	Measure of effect	Statistical approach¹	Intervention	Control
Barber 2008	Beta coefficient: 0.0235 (Cash transfer, instrumental variable model; p. 1411, Barber 2008)	Calculate exp(beta) to get OR and CI	712	180
Basinga 2011	Beta (95% CI): 0.008 (‐0.063 to 0.079)	Calculate exp(beta) to get OR and CI	Reported only the total n, stated as = 2223
Fottrell 2013	Adjusted Odds Ratio (95%CI) 1.37 (0.99 to 1.88)	Cluster adjusted, straight into RevMan	9106	8834
Kenyon 2012	RR = 1.01 (95% CI 0.91 to 1.13)	Non‐cluster trial, calculated OR	322/599	320/604
Kirkwood 2013	RR 1·02 (0·96 to 1·09)	Adjusted using ICC 0.02	5975/7859	5988/8121
Lund 2012	Adjusted OR 2.39 (1.03 to 5.55) adjusted for cluster effect and significant variables	Cluster adjusted, straight into RevMan	574/1311	385/1239
Mori 2015	Adjusted OR 1.25 (0.31 to 5.00) trial statistician (H Noma) calculated unpublished OR for this systematic review. OR adjusted for cluster effect and significant variables.	Cluster adjusted, straight into RevMan	243/252	237/248
Morris 2004 (Household package arm and service package arm added together)	Calculated from change scores, Table 2 Program effects p. 2034 of main report.	Adjusted using ICC 0.02	166/293 + 112/232	151/313
Walker 2013	Adjusted OR 95% CI 1.8(1.2 to 2.8). OR adjusted various characteristics and cluster ('in accordance with WHO standards' from Table 3, p. 1203 Walker 2013)	Cluster adjusted, straight into RevMan	78/1129	39/924
¹Main analysis with ICC of 0.02. We decided to use the same ICC for this outcome as for Proportion of women with one ANC visit. ICC of 0.02 provided in Manandhar 2004 and Wu 2011. We performed sensitivity analyses with the ICC of 0.08, a midrange of the ICC values in Pagel 2011.

Table 1. Primary outcome 1.1 Proportion of women with at least 4 ANC visits

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Table 2. Primary outcome 1.2 Pregnancy related deaths

Study	Measure of effect	Statistical approach¹	Intervention	Control
Lewycka 2013² women's groups only		Adjusted	14/4773	15/2530
Lewycka 2013a peer counselling only		Adjusted	18/4690	14/2529
Lund 2014		Adjusted	4/1351	1/1286
Majoko 2007	OR 1.94 (0.31‐15.2)	Adjusted raw data because the reported OR is asymmetrical. No reply from trial authors regarding our query.	4/6696	2/6483
Manandhar 2004		Adjusted	2/2899	11/3226
More 2012		Adjusted	20/7656	24/7536
Mori 2015		Continuity correction for no events in either treatment arm. Unpublished data provided by trial author	0/252	0/248
Persson 2013		Adjusted	1/11,906	4/10655
Fottrell 2013		Adjusted	14/8819	23/8602
Villar 2001		Adjusted	7/11672	6/11121
¹All data adjusted using an ICC of 0.00247 as suggested by Professor J P Souza by email. ²Mortality data from Trial Profile (Lewycka 2013, p. 1724). Control group (n = 5059) split for this analysis.

Table 2. Primary outcome 1.2 Pregnancy related deaths

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Table 3. SOF outcome 1.3 ANC coverage: one or more visits

Study	Measure of effect	Statistical approach¹	Intervention	Control
Basinga 2011	beta (95% CI): 0.002 (‐0.021 to 0.025);	Calculated ln (OR) and se (ln OR)	Reported only the total n = 2309
Baqui 2008		Adjusted	2297/3421	828/1689
Darmstadt 2010		Adjusted	1192/1732	864/1759
Manandhar 2004	Adjusted OR 2.82 (1.41 to 5.62)	Straight into RevMan. Worked out what ICC they used to adjust for clustering	1747/3190	1051/3524
Mori 2015	Adjusted OR 1.02 (0.01 to 131.42) trial statistician provided unpublished OR adjusted for clustering and significant variables	Straight into RevMan	252/252	248/248
Persson 2013	Adjusted OR 2.27 95% CI 1.07 to 4.80. For years 1‐3.	Straight into RevMan	596/656	482/587
¹ICC of 0.02 provided in Manandhar 2004 and Wu 2011.

Table 3. SOF outcome 1.3 ANC coverage: one or more visits

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Table 4. SOF outcome 1.6 Deliveries in health facilities

Study	Measure of effect	Statistical approach¹	Intervention	Control
Barber 2008		Adjusted	480/776	130/203
Basinga 2011	beta (95% CI): 0.081 (0.015 to 0.146)	Calculated ln (OR) and se (ln OR)	Reported only total n = 2108
Darmstadt 2010		Adjusted	350/1732	290/1759
Fottrell 2013	Adjusted Odds Ratio (95%CI) 1.05 (0.88 to 1.25)	Straight into RevMan
Kirkwood 2013		Adjusted	5373/7859	5539/8121
Mojoko 2007	Adjusted OR for delivery at health centre 1.7 (0.88 to 3.0) ICC used 0.103	Decided to use delivery at health centre outcome rather than hospital outcome. The OR is asymmetrical so will not go in RevMan ‐ have adjusted the data using the reported ICC 0.103	Health centre 2660/5261	1986/5137
Manandhar 2004		Adjusted	201/2945	66/3270
More 2012	Adjusted OR 0.92 (0.58 to 1.47)	Straight into RevMan	6602 / 7656	6573/ 7536
Penfold 2014		Adjusted	187/256	166/254
Persson 2013	Adjusted OR 1.88 95% CI 0.60 to 5.87. For years 1‐3.	Straight into RevMan	594/656	510/587
¹Data adjusted using ICC 0.103 from Majoko 2007.

Table 4. SOF outcome 1.6 Deliveries in health facilities

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Table 5. SOF outcome 1.12 Low birth weight

Trial	Measure of effect	Statistical approach¹	Intervention	Control
Kenyon 2012	RR 0.92 (0.74, 1.14) P = 0.43	Not cluster trial ‐ calculated OR	127/605	141/613
Mori 2015	Adjusted OR 0.65 (0.26 to 1.59) trial statistician (H Noma) calculated unpublished OR adjusted for cluster effects and significant variables	Straight into RevMan	8/251	12/247
Richter 2014		Adjusted	67/377	52/414
Villar 1992	OR 0.88 (95% CI 0.67 to 1.16)	Straight into RevMan	115/1033	130/1040
Villar 2001		Adjusted	910/11534	852/11040
¹ICC from Piaggio 2001 paper of 0.0004 for ANC trial with average cluster size 426.

Table 5. SOF outcome 1.12 Low birth weight

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Table 6. SOF outcome 1.13 Perinatal mortality

Trial	Effect Measure	Statistical approach¹	Intervention	Control
Baqui 2008		Adjusted	2552/32279	1260/15914
Darmstadt 2010		Adjusted	224/4800	255/5472
Fottrell 2013	Risk Ratio (95% CI) adjusted without Tea‐garden residents 0.87 (0.62 to 1.22)	Calculated OR	474/9106	503/8834
Kenyon 2012	RR 2.04 (0.51 to 8.12) P = 0.30	Not a cluster trial. Calculated adjusted OR	6/604	3/616
Kirkwood 2013		Adjusted	288/8035	355/8294
Lewycka 2013a peer counselling only		Adjusted	150/4690	103/2529
Lewycka 2013 women's groups only		Adjusted	173/4773	104/2530
Lund 2012	Adjusted OR 0.50 (0.27 to 0.93) adjusted for clustering and covariates associated with perinatal mortality	Straight into RevMman	25/1300	44/1236
Majoko 2007	OR 1.11 (0.89 to 1.39)		185/6614	161/6384
Manandhar 2004		Adjusted as below	123/2972	147/3303
More 2012		Adjusted	205/8017	173/7844
Mori 2015	Unpublished OR 0.49 (0.05 to 4.54) provided by trial statistician (H Noma) adjusted for cluster effect and significant variables	Straight into RevMan	1/253	2/248
Persson 2013		Adjusted	283/11906	290/10655
Villar 1992	OR 0.89 (95% CI 0.55 to 1.47)	Straight into RevMan	3.6% of 1033	4% of 1040
Villar 2001 (WHO 2001)	From Vogel 2013 Adjusted RR 1.18 (1.01 to 1.37). Adjusted for clustering and for risk strata, smoking, education less than primary, hospital admission in last pregnancy, previous surgery on reproductive tract, late booking, vaginal bleeding in the first trimester, age, previous low birth weight, parity.	Calculated adjusted OR	234/11672	190/11121
¹Piaggio 2001 reports ICC for perinatal mortality of 0.

Table 6. SOF outcome 1.13 Perinatal mortality

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Table 7. Primary outcome 2.1: Proportion of women with at least 4 ANC visits

Study	Measure of effect	Statistical approach¹	Intervention	Control
Bhutta 2011		Adjusted	302/2339	191/2135
Laken 1995		Not cluster trial – two intervention arms added together. calculated ln (OR) and se (Ln OR)	104/194	101/101
Le Roux 2013	1.00 (0.74, 1.34) OR Random effects logistic regression, adjusted for neighbourhood clustering. Models for outcomes among HIV‐positive mothers control for baseline employment.	Straight into RevMan	474/608	439/549
Morris 2004 both packages		Calculated from change scores, Table 2 Program effects p. 2034 of main report. Intervention 38.1% + 18.4% = 56.5% of the final sample size in this group which is 110; 48.9% ‐ 0.7% = 48.2 % in the control group (n = 313). Adjusted as below	62/110	151/313
Manthip 2015		Adjusted	62/127	53/190
Wu 2011		Calculated adjusted SE from P value 0.246	376/673	253/591
¹Primary analysis using ICC of 0.02.

Table 7. Primary outcome 2.1: Proportion of women with at least 4 ANC visits

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Table 8. Primary outcome 2.2: Pregnancy related deaths

Study	Measure of effect	Statistical approach	Intervention	Control
Kumar 2008		Adjusted	12/2749	10/1142
Laken 1995	0.9713 (0.0191 to 49.4211)	Straight into RevMan	0/104	0/101
Lewycka 2013		Adjusted	23/4601	29/5059
¹All data adjusted using an ICC of 0.00247 as suggested by Professor J P Souza by email.

Table 8. Primary outcome 2.2: Pregnancy related deaths

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Table 9. SOF outcome 2.3 ANC coverage: one or more ANC visits

Study	Measure of effect	Statistical approach¹	Intervention	Control
Bhutta 2011		Adjusted	1616/2339	1230/2135
Kumar 2008	24.5% of 2681 intervention and 14.4% of 1129 controls: RR (95%CI); 1.67 (1.47 to 1.91)	Calculated adjusted OR	657/2681	163/1129
Wahlstrom 2011		Adjusted	99/127	122/190
Midhet 2010		Adjusted	Womens group 254/836 couples group 187/703 women + couples = 441/1539	191/1022
Wu 2011		Calculated the ICC that they used to adjust the results using the reported P = 0.758	85/88	74/77
¹As for first comparison, ICC of 0.02 used for this outcome. Both Manandhar 2004 and Wu 2011 use ICCS of approximately 0.02

Table 9. SOF outcome 2.3 ANC coverage: one or more ANC visits

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Table 10. SOF outcome 2.6 Deliveries in health facilities

Study	Measure of effect	Statistical approach¹	Intervention	Control
Bhutta 2011		Adjusted as below	1272/2339	936/2135
Kumar 2008	RR (95%CI); 1.35 (0.88 to 2.07)	Calculated adjusted OR	507/2681	158/1129
Laken 1995		NOT A CLUSTER TRIAL ‐ calculated OR and confidence interval	104/104	101/101
Midhet 2010		Adjusted as below	46/ 836 in women's group 42/703 in couple's group Combined intervention arms: 88/1539	39/1022
Wu 2011		Calculated what the ICC would have been using the reported adjusted p‐value (P = 0.231)	625/673	517/591
¹ICC from Wu (0.099).

Table 10. SOF outcome 2.6 Deliveries in health facilities

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Table 11. SOF outcome 2.10 Low birthweight

Trial	Statistical approach¹	Intervention	Control
Klerman 2001	Straight into RevMan ‐ not cluster trial	39/311	33/296
Le roux 2013	Calculated adjusted OR	88/608	123/549
ICC from Piaggio paper of 0.0004 for ANC trial with average cluster size 426

Table 11. SOF outcome 2.10 Low birthweight

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Table 12. SOF outcome 2.11 Perinatal deaths

Trial	Statistical approach¹	Intervention	Control
Bhutta 2011	Calculated OR	880/12028	972/11005
Laken 1995	Calculated OR	0/96	0/91
Lewycka 2013	Calculated OR	198/4601	207/5059
Midhet 2010	Calculated OR	Women's group 36/836 plus couple's group 42/703	Control 86/1022
Kumar 2008	Calculated OR	219/ 2609	155/ 1079
¹Piaggio 2001 reports and ICC of 0 for perinatal deaths.

Table 12. SOF outcome 2.11 Perinatal deaths

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Comparison 1. One intervention versus no intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	10		Odds Ratio (Random, 95% CI)	Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Kirkwood and Morris)	10	45022	Odds Ratio (Random, 95% CI)	1.11 [1.01, 1.22]
1.2 Sensitivity analysis using ICC 0.08	10	45022	Odds Ratio (Random, 95% CI)	1.11 [1.00, 1.22]
2 Pregnancy‐related deaths Show forest plot	10	114930	Odds Ratio (Random, 95% CI)	0.69 [0.45, 1.08]

3 ANC coverage: one or more visits Show forest plot	6		Odds Ratio (Random, 95% CI)	1.68 [1.02, 2.79]

4 Pregnant women initiating ANC in first trimester Show forest plot	1		Odds Ratio (Random, 95% CI)	1.20 [0.99, 1.45]

5 Pregnant women receiving ANC from health professional Show forest plot	1		Odds Ratio (Random, 95% CI)	1.13 [0.84, 1.52]

6 Deliveries in a health facility Show forest plot	10		Odds Ratio (Random, 95% CI)	1.08 [1.02, 1.15]

7 Intermittent Prophylactic Treatment for malaria	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8 Proportion of women with tetanus protection at birth Show forest plot	8		Odds Ratio (Random, 95% CI)	1.03 [0.92, 1.15]

9 Proportion of women treated for syphilis Show forest plot	2		Odds Ratio (Random, 95% CI)	1.46 [0.94, 2.26]

10 Proportion of women with HIV who receive a complete antiretroviral course for prevention of mother‐to‐child transmission of HIV Show forest plot	1		Odds Ratio (Random, 95% CI)	0.44 [0.26, 0.74]

11 Preterm labour Show forest plot	4		Odds Ratio (Random, 95% CI)	1.00 [0.93, 1.09]

12 Low birthweight Show forest plot	5		Odds Ratio (Random, 95% CI)	0.94 [0.82, 1.06]

13 Perinatal mortality Show forest plot	15		Odds Ratio (Random, 95% CI)	0.96 [0.89, 1.03]

Comparison 1. One intervention versus no intervention

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Comparison 2. Combination of interventions versus no intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	6		Odds Ratio (Random, 95% CI)	Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Bhutta and Morris)	6	7840	Odds Ratio (Random, 95% CI)	1.48 [0.99, 2.21]
1.2 ICC 0.08	6	7840	Odds Ratio (Random, 95% CI)	1.45 [0.95, 2.23]
2 Pregnancy‐related deaths Show forest plot	3	13756	Odds Ratio (Random, 95% CI)	0.70 [0.39, 1.26]

3 ANC coverage: one or more visits Show forest plot	5		Odds Ratio (Random, 95% CI)	1.79 [1.47, 2.17]

4 Pregnant women initiating ANC in first trimester Show forest plot	1		Odds Ratio (Random, 95% CI)	0.83 [0.47, 1.47]

5 Pregnant women receiving ANC from health professional Show forest plot	2		Odds Ratio (Random, 95% CI)	2.97 [1.67, 5.30]

6 Deliveries in a health facility Show forest plot	5		Odds Ratio (Random, 95% CI)	1.53 [0.96, 2.43]

7 Intermittent Prophylactic Treatment for malaria	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8 Proportion of women with tetanus protection at birth Show forest plot	3		Odds Ratio (Random, 95% CI)	1.48 [1.18, 1.87]

9 Preterm labour Show forest plot	1	607	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.45, 1.20]

10 Low birthweight Show forest plot	2		Odds Ratio (Random, 95% CI)	0.61 [0.46, 0.80]

11 Perinatal mortality Show forest plot	5		Odds Ratio (Random, 95% CI)	0.74 [0.57, 0.95]

Comparison 2. Combination of interventions versus no intervention

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Comparison 3. Two interventions compared

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Pregnancy‐related deaths	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 ANC coverage: one or more visits	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Deliveries in a health facility	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Perinatal mortality	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Low birthweight	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Intermittent Prophylactic Treatment for malaria	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Two interventions compared

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Comparison 4. Combination of interventions versus one intervention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	2		Odds Ratio (Random, 95% CI)	0.99 [0.70, 1.40]

2 Pregnancy‐related deaths Show forest plot	2		Odds Ratio (Random, 95% CI)	1.00 [0.52, 1.96]

3 ANC coverage: one or more visits Show forest plot	3		Odds Ratio (Random, 95% CI)	0.86 [0.61, 1.20]

4 Deliveries in a health facility Show forest plot	3		Odds Ratio (Random, 95% CI)	0.95 [0.69, 1.30]

5 Perinatal mortality Show forest plot	2		Odds Ratio (Random, 95% CI)	0.88 [0.72, 1.07]

6 Proportion of women with tetanus protection at birth Show forest plot	2		Odds Ratio (Random, 95% CI)	1.07 [0.80, 1.43]

7 Low birthweight	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Intermittent Prophylactic Treatment for malaria	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Combination of interventions versus one intervention

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Comparison 5. Different combinations of interventions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	1	383	Odds Ratio (M‐H, Random, 95% CI)	0.77 [0.41, 1.43]

2 Pregnancy‐related deaths	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 ANC coverage: one or more visits	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Deliveries in a health facility Show forest plot	1	383	Odds Ratio (M‐H, Random, 95% CI)	1.55 [0.71, 3.37]

5 Perinatal mortality	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Low birthweight	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Intermittent Prophylactic Treatment for malaria	0	0	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. Different combinations of interventions

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Comparison 6. Subgroup analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Health systems vs Population ANC coverage: four or more visits Show forest plot	9		Odds Ratio (Random, 95% CI)	Subtotals only

1.1 Health system interventions	5		Odds Ratio (Random, 95% CI)	1.13 [0.96, 1.34]
1.2 Population interventions	4		Odds Ratio (Random, 95% CI)	1.04 [0.96, 1.13]
2 Health systems vs Population Pregnancy‐related deaths Show forest plot	11		Odds Ratio (Random, 95% CI)	Subtotals only

2.1 Health system interventions	4		Odds Ratio (Random, 95% CI)	1.22 [0.41, 3.65]
2.2 Population intervention	7		Odds Ratio (Random, 95% CI)	0.69 [0.46, 1.03]
3 Country Income Low vs High ANC at least 4 visits Show forest plot	18		Odds Ratio (Random, 95% CI)	1.14 [1.04, 1.25]

3.1 Low or lower middle income countries	11		Odds Ratio (Random, 95% CI)	1.21 [1.04, 1.40]
3.2 High or higher middle income countries	7		Odds Ratio (Random, 95% CI)	1.12 [0.95, 1.32]

Comparison 6. Subgroup analysis

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Comparison 7. One intervention versus no intervention ‐ Sensitivity analysis by risk of bias

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	9		Odds Ratio (Random, 95% CI)	Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Kirkwood and Morris)	9		Odds Ratio (Random, 95% CI)	1.07 [0.99, 1.15]
1.2 Sensitivity analysis using ICC 0.08	9		Odds Ratio (Random, 95% CI)	1.05 [0.98, 1.14]

Comparison 7. One intervention versus no intervention ‐ Sensitivity analysis by risk of bias

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Comparison 8. Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ANC coverage: four or more visits Show forest plot	4		Odds Ratio (Random, 95% CI)	Subtotals only

1.1 Primary analysis (ICC 0.02 for studies Bhutta and Morris)	4		Odds Ratio (Random, 95% CI)	1.07 [0.82, 1.40]
1.2 ICC 0.08	4		Odds Ratio (Random, 95% CI)	1.03 [0.77, 1.37]

Comparison 8. Combination of interventions versus no intervention ‐ Sensitivity analysis by risk of bias

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