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Cochrane Database of Systematic Reviews

Administración prenatal de suplementos dietéticos con mioinositol en pacientes embarazadas para prevenir la diabetes gestacional

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Información

DOI:
https://doi.org/10.1002/14651858.CD011507.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 17 diciembre 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Embarazo y parto

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Tineke J Crawford

    Liggins Institute, The University of Auckland, Auckland, New Zealand

  • Caroline A Crowther

    Liggins Institute, The University of Auckland, Auckland, New Zealand

    ARCH: Australian Research Centre for Health of Women and Babies, Robinson Research Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia

  • Jane Alsweiler

    Neonatal Intensive Care Unit, Auckland Hospital, Auckland, New Zealand

  • Julie Brown

    Correspondencia a: Liggins Institute, The University of Auckland, Auckland, New Zealand

    [email protected]

Contributions of authors

Tineke Crawford is guarantor for this review.

Tineke Crawford screened search results, retrieved relevant papers, screened retrieved papers against eligibility criteria, appraised quality of papers, extracted data from papers, wrote to authors of papers for additional information, entered data into RevMan, analysed and interpreted data, wrote the first draft of the review, incorporated feedback into subsequent versions of the review.

Julie Brown conceived the review, screened retrieved papers against eligibility criteria, appraised quality of papers, extracted data from papers, checked data in RevMan, analysed and interpreted data, providing a methodological perspective, contributed to subsequent versions of the review.

Jane Alsweiler appraised quality of papers, extracted data from papers, analysed and interpreted data, providing a neonatal clinical perspective, and contributed to subsequent versions of the review.

Caroline Crowther provided a maternal clinical and methodological perspective.

Sources of support

Internal sources

  • None, Other.

External sources

  • The Cochrane Pregnancy and Childbirth Review Group editorial team, Liverpool, UK.

  • The Australasian Satellite of the Cochrane Pregnancy and Childbirth Review Group (Funded by NHMRC), Adelaide, Australia.

    (incorporating the New Zealand branch)

  • The Liggins Institute, The University of Auckland, New Zealand.

Declarations of interest

Professor Caroline Crowther, Dr Julie Brown and Dr Jane Aslweiler are investigators on a planned trial of myo‐inositol supplements in pregnancy for the prevention of gestational diabetes. If this trial is eligible for inclusion in this review, Professor Caroline Crowher, Dr Julie Brown and Dr Jane Aslweiler will not be involved in any aspect of data extraction or risk of bias relating to this trial. Tineke Crawford and another researcher not involved in the trial will deal with the handling of these data.

Acknowledgements

Dahineswari Rajamanickam assisted the review authors in preparing the first draft of the protocol.

Portions of the methods section of this protocol are based on a standard template used by the Cochrane Pregnancy and Childbirth Review Group. Outcomes may be similar to other Cochrane reviews for preventing gestational diabetes due to the attempt to have consistent outcomes for reviews on this condition.

We acknowledge the support from the Cochrane Pregnancy and Childbirth Review Group editorial team in Liverpool, the Australian and New Zealand Satellite of the Cochrane Pregnancy and Childbirth Review Group (funded by NHMRC) and the Liggins Institute, University of Auckland, New Zealand.

As part of the pre‐publication editorial process, this review has been commented on by three peers (an editor and two referees who are external to the editorial team) and the Group's Statistical Adviser.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2023 Feb 15

Antenatal dietary supplementation with myo‐inositol for preventing gestational diabetes

Review

Soana K Motuhifonua, Luling Lin, Jane Alsweiler, Tineke J Crawford, Caroline A Crowther

https://doi.org/10.1002/14651858.CD011507.pub3

2015 Dec 17

Antenatal dietary supplementation with myo‐inositol in women during pregnancy for preventing gestational diabetes

Review

Tineke J Crawford, Caroline A Crowther, Jane Alsweiler, Julie Brown

https://doi.org/10.1002/14651858.CD011507.pub2

2015 Feb 04

Myo‐inositol for preventing gestational diabetes

Protocol

Julie Brown, Tineke J Crawford, Jane Alsweiler, Caroline A Crowther

https://doi.org/10.1002/14651858.CD011507

Differences between protocol and review

There are some differences between our published protocol (Brown 2015) and the full review.

The title was listed as Myo‐inositol for preventing gestational diabetes in our published protocol but we have edited this to Antenatal dietary supplementation with myo‐inositol in women during pregnancy for preventing gestational diabetes in order to allow more clarity around the intervention, population and outcome.

Methods/Criteria for considering studies for this review

Types of interventions: we have expanded this section to include myo‐inositol in a combination preparation; this is also reflected in our list of planned subgroup analyses.

Types of participants: we have clarified that participants will be pregnant women rather than pregnant women at risk of gestational diabetes mellitus (GDM).

We have incorporated the use of GRADE to assess the quality of the body of evidence and have included 'Summary of findings' tables; this was not pre‐specified in our published protocol.

We have reported on the outcome 'need for supplementary insulin therapy' ‐ whilst this is not listed in our methods/outcomes section (and was not pre‐specified in our published protocol), we report on this outcome for interest.

Following a consultative process with Professor Caroline Crowther, Dr Julie Brown, Dr Philippa Middleton, Emily Bain and Tineke Crawford, a core set of primary and secondary outcomes for GDM systematic reviews and core outcomes for GRADE assessment for GDM systematic reviews were drawn up. This has resulted in a number of changes detailed below. These core outcomes were agreed upon after this review had been submitted for peer review.

Additionally, as this is a review on the use of a dietary supplement as an intervention, adverse effects of the intervention has been added as an outcome.

Previous maternal primary outcomes listed in protocol

  1. Incidence of gestational diabetes mellitus (GDM) (diagnostic criteria as defined in individual trials)

  2. Pre‐eclampsia

  3. Caesarean section

Updated maternal primary outcomes used in review

  1. Gestational diabetes mellitus (GDM)

  2. Hypertensive disorders of pregnancy (including pre‐eclampsia, eclampsia, pregnancy‐induced hypertension)

Previous neonatal primary outcomes listed in protocol

  1. Large‐for‐gestational age (birthweight greater than the 90th centile; or as defined by individual trial)

  2. Perinatal mortality

  3. Death or morbidity composite (variously defined by trials, e.g. infant death, shoulder dystocia, bone fracture or nerve palsy)

Updated neonatal primary outcomes used in review

  1. Large‐for‐gestational age (birthweight greater than the 90th centile; or as defined by individual trial)

  2. Perinatal mortality (stillbirth and neonatal mortality)

  3. Mortality or morbidity composite (variously defined by trials, e.g. infant death, shoulder dystocia, bone fracture or nerve palsy)

Previous maternal secondary outcomes listed in protocol

  1. Postnatal weight retention

  2. Body mass index (BMI)

  3. Development of type 2 diabetes mellitus

  4. Development of type 1 diabetes mellitus

  5. Impaired glucose tolerance (as defined in individual trials)

  6. Insulin sensitivity (as defined in individual trials)

  7. Incidence of pregnancy hyperglycaemia not meeting GDM diagnostic criteria (diagnostic criteria as defined in individual trials)

  8. Induction of labour

  9. Perineal trauma

  10. Weight gain during pregnancy

  11. Adiponectin levels

  12. Gestational age at screening for GDM

  13. Postpartum haemorrhage

  14. Postpartum infection

  15. Placental abruption

  16. Polyhydramnios

  17. Compliance with treatment

  18. Breastfeeding at discharge, six weeks' postpartum

  19. Women’s sense of well‐being and quality of life (as defined in individual trials)

  20. Women’s view of intervention

Updated maternal secondary outcomes used in review

  1. Caesarean section

  2. Placental abruption

  3. Induction of labour

  4. Perineal trauma

  5. Postpartum haemorrhage

  6. Postpartum infection

  7. Weight gain during pregnancy

  8. Adherence to the intervention (as defined by trialists)

  9. Behaviour changes associated with the intervention (as defined by trialists)

  10. Relevant biomarker changes associated with the intervention (e.g. adiponectin, free fatty acids, triglycerides, high density lipoproteins, low density lipoproteins, insulin)

  11. Sense of well‐being and quality of life

  12. Views of the intervention

  13. Breastfeeding (e.g. at discharge, six weeks postpartum)

  14. Adverse effects of intervention

Long‐term maternal outcomes

  1. Postnatal depression

  2. Postnatal weight retention or return to pre‐pregnancy weight

  3. Body mass index (BMI)

  4. Gestational diabetes mellitus in a subsequent pregnancy

  5. Type I diabetes mellitus

  6. Type II diabetes mellitus

  7. Impaired glucose tolerance

  8. Cardiovascular health (as defined by trialists, including blood pressure (BP), hypertension, cardiovascular disease, metabolic syndrome)

Previous neonatal secondary outcomes listed in protocol

  1. Macrosomia (as defined in individual trials)

  2. Birthweight and z‐score

  3. Head circumference and z‐score

  4. Length and z‐score

  5. Small‐for‐gestational age (as defined in individual trials)

  6. Neonatal hypoglycaemia requiring treatment (as defined in individual trials)

  7. Gestational age at birth

  8. Preterm birth (less than 37 weeks’ gestational age)

  9. Shoulder dystocia

  10. Bone fracture

  11. Nerve palsy

  12. Respiratory distress syndrome

  13. Hyperbilirubinaemia requiring treatment (as defined in individual trials)

  14. Apgar scores (less than seven at five minutes)

  15. Ponderal index

  16. Fetal adiposity (as defined in individual trials)

  17. Neonatal glucose concentration

  18. Infant mortality (fetal, neonatal, perinatal)

Updated secondary outcomes used in review

  1. Stillbirth

  2. Neonatal mortality

  3. Gestational age at birth

  4. Preterm birth (less than 37 weeks' gestation and less than 32 weeks' gestation)

  5. Apgar score (less than seven at five minutes)

  6. Macrosomia

  7. Small‐for‐gestational age

  8. Birthweight and z‐score

  9. Head circumference and z‐score

  10. Length and z‐score

  11. Ponderal index

  12. Adiposity

  13. Shoulder dystocia

  14. Bone fracture

  15. Nerve palsy

  16. Respiratory distress syndrome

  17. Hypoglycaemia (variously defined)

  18. Hyperbilirubinaemia

Previous childhood outcomes listed in protocol

  1. Weight

  2. Height

  3. Head circumference

  4. Body mass index

  5. Adiposity (fat mass/fat free mass (variously measured))

  6. Blood pressure

  7. Impaired glucose tolerance (as defined in individual trials)

  8. Development of type 1 diabetes mellitus

  9. Development of type 2 diabetes mellitus

  10. Insulin sensitivity

  11. Dyslipidaemia or metabolic syndrome

  12. Neurodisability

  13. Educational achievement

Updated childhood outcomes used in review

  1. Weight and z scores

  2. Height and z scores

  3. Head circumference and z scores

  4. Adiposity (e.g. as measured by BMI, skinfold thickness)

  5. Blood pressure

  6. Type I diabetes mellitus

  7. Type II diabetes mellitus

  8. Impaired glucose tolerance

  9. Dyslipidaemia or metabolic syndrome

  10. Neurodisability

  11. Educational achievement

Previous adulthood outcomes listed in protocol

  1. Weight

  2. Height

  3. BMI

  4. Adiposity (fat mass/fat‐free mass (variously measured))

  5. Blood pressure

  6. Impaired glucose tolerance (as defined in individual trials)

  7. Development of type 1 diabetes

  8. Development of type 2 diabetes

  9. Insulin sensitivity (as defined in individual trials)

  10. Dyslipidaemia or metabolic syndrome

  11. Educational achievement

Updated adulthood outcomes used in review

  1. Weight

  2. Height

  3. Adiposity (e.g. as measured by BMI, skinfold thickness)

  4. Cardiovascular health (as defined by trialists, including BP, hypertension, cardiovascular disease, metabolic syndrome)

  5. Type I diabetes mellitus

  6. Type II diabetes mellitus

  7. Impaired glucose tolerance

  8. Dyslipidaemia or metabolic syndrome

  9. Employment, education and social status/achievement

Previous health services cost outcomes listed in protocol

  1. Number of hospital visits or health professional visits (e.g. midwife, obstetrician, physician, dietitian)

  2. Antenatal visits for mother

  3. Direct costs to families in relation to the management provided

  4. Length of postnatal stay (mother)

  5. Admission to neonatal ward/ neonatal intensive care unit

  6. Length of postnatal stay (baby)

  7. Cost of maternal care

  8. Cost of offspring care

Updated health services cost outcomes used in review

  1. Number of hospital or health professional visits (e.g. midwife, obstetrician, physician, dietitian, diabetic nurse)

  2. Number of antenatal visits or admissions

  3. Length of antenatal stay

  4. Neonatal intensive care unit admission

  5. Length of postnatal stay (mother)

  6. Length of postnatal stay (baby)

  7. Costs to families associated with the management provided

  8. Costs associated with the intervention

  9. Cost of maternal care

  10. Cost of offspring care

Previous GRADE outcomes listed in protocol

  1. Incidence of GDM (diagnostic criteria as defined in individual trials)

  2. Pre‐eclampsia

  3. Mode of birth

  4. Large‐for‐gestational age (birthweight greater than the 90th centile; or as defined by individual trial)

  5. Perinatal mortality

  6. Fetal adiposity

  7. Impaired glucose tolerance as child/adult

Updated GRADE outcomes used in review

Maternal

  1. Diagnosis of GDM

  2. Gestational weight gain

  3. Hypertensive disorders of pregnancy (including pre‐eclampsia, eclampsia, pregnancy‐induced hypertension)

  4. Caesarean Section

  5. Perineal trauma

  6. Postnatal depression

  7. Development of subsequent type II diabetes mellitus

Offspring (infant, child, adult)

  1. Large‐for‐gestational age

  2. Perinatal mortality (stillbirth and neonatal mortality)

  3. Composite of serious neonatal outcomes

  4. Neonatal hypoglycaemia (variously defined)

  5. Offspring adiposity (e.g. as measured by BMI, skinfold thickness)

  6. Offspring diabetes

  7. Neurosensory disability

Keywords

MeSH

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.

‐Study flow diagram.
Figuras y tablas -
Figure 1

‐Study flow diagram.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

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

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

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

Comparison 1 Myo‐inositol versus control, Outcome 1 Gestational diabetes mellitus.
Figuras y tablas -
Analysis 1.1

Comparison 1 Myo‐inositol versus control, Outcome 1 Gestational diabetes mellitus.

Comparison 1 Myo‐inositol versus control, Outcome 2 Fasting OGTT.
Figuras y tablas -
Analysis 1.2

Comparison 1 Myo‐inositol versus control, Outcome 2 Fasting OGTT.

Comparison 1 Myo‐inositol versus control, Outcome 3 One hour OGTT.
Figuras y tablas -
Analysis 1.3

Comparison 1 Myo‐inositol versus control, Outcome 3 One hour OGTT.

Comparison 1 Myo‐inositol versus control, Outcome 4 Two hour OGTT.
Figuras y tablas -
Analysis 1.4

Comparison 1 Myo‐inositol versus control, Outcome 4 Two hour OGTT.

Comparison 1 Myo‐inositol versus control, Outcome 5 Hypertensive disorders of pregnancy.
Figuras y tablas -
Analysis 1.5

Comparison 1 Myo‐inositol versus control, Outcome 5 Hypertensive disorders of pregnancy.

Comparison 1 Myo‐inositol versus control, Outcome 6 Caesarean section.
Figuras y tablas -
Analysis 1.6

Comparison 1 Myo‐inositol versus control, Outcome 6 Caesarean section.

Comparison 1 Myo‐inositol versus control, Outcome 7 Weight gain during pregnancy.
Figuras y tablas -
Analysis 1.7

Comparison 1 Myo‐inositol versus control, Outcome 7 Weight gain during pregnancy.

Comparison 1 Myo‐inositol versus control, Outcome 8 Relevant biomarker changes associated with the intervention.
Figuras y tablas -
Analysis 1.8

Comparison 1 Myo‐inositol versus control, Outcome 8 Relevant biomarker changes associated with the intervention.

Comparison 1 Myo‐inositol versus control, Outcome 9 Adverse effects of intervention.
Figuras y tablas -
Analysis 1.9

Comparison 1 Myo‐inositol versus control, Outcome 9 Adverse effects of intervention.

Comparison 1 Myo‐inositol versus control, Outcome 10 Supplementary insulin.
Figuras y tablas -
Analysis 1.10

Comparison 1 Myo‐inositol versus control, Outcome 10 Supplementary insulin.

Comparison 1 Myo‐inositol versus control, Outcome 11 Gestational age at birth.
Figuras y tablas -
Analysis 1.11

Comparison 1 Myo‐inositol versus control, Outcome 11 Gestational age at birth.

Comparison 1 Myo‐inositol versus control, Outcome 12 Preterm birth (less than 37 weeks' gestation).
Figuras y tablas -
Analysis 1.12

Comparison 1 Myo‐inositol versus control, Outcome 12 Preterm birth (less than 37 weeks' gestation).

Comparison 1 Myo‐inositol versus control, Outcome 13 Macrosomia.
Figuras y tablas -
Analysis 1.13

Comparison 1 Myo‐inositol versus control, Outcome 13 Macrosomia.

Comparison 1 Myo‐inositol versus control, Outcome 14 Birthweight.
Figuras y tablas -
Analysis 1.14

Comparison 1 Myo‐inositol versus control, Outcome 14 Birthweight.

Comparison 1 Myo‐inositol versus control, Outcome 15 Shoulder dystocia.
Figuras y tablas -
Analysis 1.15

Comparison 1 Myo‐inositol versus control, Outcome 15 Shoulder dystocia.

Comparison 1 Myo‐inositol versus control, Outcome 16 Respiratory distress syndrome.
Figuras y tablas -
Analysis 1.16

Comparison 1 Myo‐inositol versus control, Outcome 16 Respiratory distress syndrome.

Comparison 1 Myo‐inositol versus control, Outcome 17 Neonatal hypoglycaemia.
Figuras y tablas -
Analysis 1.17

Comparison 1 Myo‐inositol versus control, Outcome 17 Neonatal hypoglycaemia.

Summary of findings for the main comparison. Myo‐inositol for preventing gestational diabetes maternal outcomes (maternal outcomes)

Antenatal supplementation with myo‐inositol for preventing gestational diabetes

Patient or population: pregnant women (women with pre‐existing type 1 or type 2 diabetes are NOT included)
Intervention: Myo‐inositol

Setting: Italy
Comparison: Control

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control

Risk with Myo‐inositol

Gestational diabetes mellitus

Study population

RR 0.43
(0.29 to 0.64)

502
(3 RCTs)

⊕⊕⊝⊝
LOW 1 2

GDM diagnosed using IADPSG 2010 criteria

28 per 100

12 per 100
(8 to 18)

Weight gain during pregnancy

The mean weight gain during pregnancy was 0

The mean weight gain during pregnancy in the intervention group was 0.64 more (0.41 fewer to 1.7 more)

411
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 2 3 4

D'Anna 2015 included obese pregnant women and D'Anna 2013 included non‐obese women with a family history of type 2 diabetes

Random‐effects model

Hypertensive disorders of pregnancy

Study population

RR 0.43
(0.02 to 8.41)

398
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 2 5 6

Random‐effects model

4 per 100

2 per 100
(0 to 33)

Caesarean section

Study population

RR 0.95
(0.76 to 1.19)

398
(2 RCTs)

⊕⊕⊝⊝
LOW 2 6

45 per 100

43 per 100
(34 to 54)

Perineal trauma

Not estimable

(0 studies)

No data reported for perineal trauma in any of the included studies

Postnatal depression

Not estimable

(0 studies)

No data reported for postnatal depression in any of the included studies

Type 2 diabetes

Not estimable

(0 studies)

No data reported for type 2 diabetes in any of the included studies

*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

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 Downgraded (‐1) due to unclear risk of bias for allocation concealment in two of the included trials (one trial did not provide sufficient detail to determine allocation concealment and one trial (reported as a conference abstract) had no details of random sequence generation, allocation concealment or blinding) and for high risk of performance bias for lack of blinding (two trials were open‐label trials with no blinding of participants or researchers, however one trial explicitly described blinding of outcome assessors and was assessed as low risk of detection bias).

2 Studies were conducted in Italy with Caucasian women and generalisability of findings is limited, downgraded (‐1).

3 Evidence of imprecision with wide confidence intervals crossing the line of no effect, downgraded (‐1).

4 Heterogeneity high with I2 = 54% (indirectness) probably due to different study populations, downgraded (‐1).

5 Wide confidence intervals with very low event rates and a small sample size suggest evidence of imprecision, downgraded (‐1).

6 Downgraded (‐1) due to insufficient evidence to judge allocation concealment in one trial and subsequent judgement of unclear risk of bias. The other trial had a low risk of bias for allocation concealment. Both trials were open‐label with no blinding of participants or researchers, although one trial explicitly stated that outcome assessors were blinded to treatment allocation.

Figuras y tablas -
Summary of findings for the main comparison. Myo‐inositol for preventing gestational diabetes maternal outcomes (maternal outcomes)
Summary of findings 2. Myo‐inositol for preventing gestational diabetes (neonatal, child and adult outcomes)

Antenatal supplementation with myo‐inositol for preventing gestational diabetes

Patient or population: pregnant women who were at risk of GDM

Setting: Italy
Intervention: Myo‐inositol
Comparison: Control

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control

Risk with Myo‐inositol

Large‐for‐gestational age

not estimable

(0 studies)

No data reported for large‐for‐gestational age in any of the included studies

Perinatal mortality

not estimable

(0 studies)

No data reported for perinatal mortality in any of the included studies

Composite of serious neonatal outcomes

not estimable

(0 studies)

No data reported for composite of serious neonatal outcomes in any of the included studies

Neonatal hypoglycaemia

Study population

RR 0.36
(0.01 to 8.66)

398
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 3

0 per 100

0 per 100
(0 to 4)

Adiposity

not estimable

(0 studies)

No data reported for adiposity in any of the included studies

Diabetes

not estimable

(0 studies)

No data reported for diabetes in any of the included studies

Neurosensory disability

not estimable

(0 studies)

No data reported for neurosensory disability in any of the included studies

*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

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 No blinding in either study and reporting of allocation concealment was unclear in one of the studies, downgraded (‐1).

2 Both studies were conducted in Italy with Caucasian women and may not be generalisable to other settings, downgraded (‐1).

3 Wide confidence intervals with very low event rates suggest evidence of imprecision, downgraded (‐1).

Figuras y tablas -
Summary of findings 2. Myo‐inositol for preventing gestational diabetes (neonatal, child and adult outcomes)
Comparison 1. Myo‐inositol versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Gestational diabetes mellitus Show forest plot

3

502

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.29, 0.64]

2 Fasting OGTT Show forest plot

3

502

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.28, ‐0.12]

3 One hour OGTT Show forest plot

3

502

Mean Difference (IV, Fixed, 95% CI)

‐0.68 [1.00, ‐0.37]

4 Two hour OGTT Show forest plot

3

502

Mean Difference (IV, Random, 95% CI)

‐0.75 [‐1.07, ‐0.43]

5 Hypertensive disorders of pregnancy Show forest plot

2

398

Risk Ratio (M‐H, Random, 95% CI)

0.43 [0.02, 8.41]

6 Caesarean section Show forest plot

2

398

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.76, 1.19]

7 Weight gain during pregnancy Show forest plot

2

411

Mean Difference (IV, Random, 95% CI)

0.64 [‐0.41, 1.70]

8 Relevant biomarker changes associated with the intervention Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

8.1 Total cholesterol

1

48

Mean Difference (IV, Fixed, 95% CI)

‐47.29 [‐52.87, ‐41.71]

8.2 Low density lipoprotein

1

48

Mean Difference (IV, Fixed, 95% CI)

‐33.50 [‐39.71, ‐27.29]

8.3 High density lipoprotein

1

48

Mean Difference (IV, Fixed, 95% CI)

‐13.79 [‐18.91, ‐8.67]

8.4 Triglycerides

1

48

Mean Difference (IV, Fixed, 95% CI)

‐39.33 [‐44.00, ‐34.66]

9 Adverse effects of intervention Show forest plot

2

245

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Supplementary insulin Show forest plot

2

398

Risk Ratio (M‐H, Fixed, 95% CI)

0.48 [0.11, 2.09]

11 Gestational age at birth Show forest plot

2

398

Mean Difference (IV, Random, 95% CI)

5.50 [‐7.24, 18.24]

12 Preterm birth (less than 37 weeks' gestation) Show forest plot

2

398

Risk Ratio (M‐H, Fixed, 95% CI)

0.45 [0.17, 1.14]

13 Macrosomia Show forest plot

2

398

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.02, 6.37]

14 Birthweight Show forest plot

2

398

Mean Difference (IV, Random, 95% CI)

‐60.47 [‐265.21, 144.26]

15 Shoulder dystocia Show forest plot

2

398

Risk Ratio (M‐H, Random, 95% CI)

2.33 [0.12, 44.30]

16 Respiratory distress syndrome Show forest plot

1

197

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.06, 15.60]

17 Neonatal hypoglycaemia Show forest plot

2

398

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.01, 8.66]

Figuras y tablas -
Comparison 1. Myo‐inositol versus control