Antenatal dietary supplementation with myo‐inositol for preventing gestational diabetes

Soana K Motuhifonua<sup>a</sup>; Luling Lin<sup>a</sup>; Jane Alsweiler; Tineke J Crawford; Caroline A Crowther

doi:10.1002/14651858.CD011507.pub3

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Figure 1

Study flow diagram for updated review

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Figure 2

Applying the trustworthiness screening tool criteria. TST: Trustworthiness Screening Tool.

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Figure 3

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 4

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

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Analysis 1.1

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

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Analysis 1.2

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

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Analysis 1.3

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

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Analysis 1.4

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

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Analysis 1.5

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

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Analysis 1.6

Comparison 1: Myo‐inositol versus control, Outcome 6: Large‐for‐gestational‐age

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Analysis 1.7

Comparison 1: Myo‐inositol versus control, Outcome 7: Caesarean section

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Analysis 1.8

Comparison 1: Myo‐inositol versus control, Outcome 8: Weight gain during pregnancy

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Analysis 1.9

Comparison 1: Myo‐inositol versus control, Outcome 9: Relevant biomarker changes associated with the intervention

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Analysis 1.10

Comparison 1: Myo‐inositol versus control, Outcome 10: Perineal trauma

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Analysis 1.11

Comparison 1: Myo‐inositol versus control, Outcome 11: Postpartum haemorrhage

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Analysis 1.12

Comparison 1: Myo‐inositol versus control, Outcome 12: Adherence to intervention

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Analysis 1.13

Comparison 1: Myo‐inositol versus control, Outcome 13: Supplementary insulin

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Analysis 1.14

Comparison 1: Myo‐inositol versus control, Outcome 14: Gestational age at birth

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Analysis 1.15

Comparison 1: Myo‐inositol versus control, Outcome 15: Preterm birth (less than 37 weeks' gestation)

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Analysis 1.16

Comparison 1: Myo‐inositol versus control, Outcome 16: Macrosomia

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Analysis 1.17

Comparison 1: Myo‐inositol versus control, Outcome 17: Birthweight

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Analysis 1.18

Comparison 1: Myo‐inositol versus control, Outcome 18: Shoulder dystocia

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Analysis 1.19

Comparison 1: Myo‐inositol versus control, Outcome 19: Respiratory distress syndrome

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Analysis 1.20

Comparison 1: Myo‐inositol versus control, Outcome 20: Neonatal hypoglycaemia

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Analysis 1.21

Comparison 1: Myo‐inositol versus control, Outcome 21: Small‐for‐gestational‐age

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Analysis 1.22

Comparison 1: Myo‐inositol versus control, Outcome 22: Neonatal hyperbilirubinaemia

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Analysis 1.23

Comparison 1: Myo‐inositol versus control, Outcome 23: Admission to neonatal intensive care unit or special care baby unit

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Summary of findings 1. Myo‐inositol for preventing gestational diabetes: maternal outcomes

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
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: hospital Comparison: folic acid or placebo
Outcomes	Risk with control	Risk with myo‐inositol	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Gestational diabetes mellitus	Study population		RR 0.53 (0.31 to 0.90)	1140 (6 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	GDM diagnosed using IADPSG 2010 criteria Random‐effects model
Gestational diabetes mellitus	217 per 1000	115 per 1,000 (67 to 196)	RR 0.53 (0.31 to 0.90)	1140 (6 RCTs)	⊕⊝⊝⊝ Very low^a,b,c
Weight gain during pregnancy	Comparator	The mean weight gain during pregnancy in the intervention group was 0.25 kg lower (1.26 kg fewer to 0.76 kg more)	‐	831 (4 RCTs)	⊕⊝⊝⊝ Very low^b,c,d,e	Random‐effects model
Hypertensive disorders of pregnancy	Study population		RR 0.34 (0.19 to 0.61)	1052 (5 RCTs)	⊕⊕⊝⊝ Low^c,f	Random‐effects model
Hypertensive disorders of pregnancy	86 per 1,000	29 per 1,000 (16 to 53)	RR 0.34 (0.19 to 0.61)	1052 (5 RCTs)	⊕⊕⊝⊝ Low^c,f	Random‐effects model
Caesarean section	Study population		RR 0.91 (0.77 to 1.07)	829 (4 RCTs)	⊕⊕⊝⊝ Low^c,g
Caesarean section	430 per 1,000	391 per 1,000 (331 to 460)	RR 0.91 (0.77 to 1.07)	829 (4 RCTs)	⊕⊕⊝⊝ Low^c,g
Perineal trauma	Study population		RR 4.00 (0.45 to 35.25)	234 (1 RCT)	⊕⊝⊝⊝ Very low^h,i,j
Perineal trauma	9 per 1,000	34 per 1,000 (4 to 301)	RR 4.00 (0.45 to 35.25)	234 (1 RCT)	⊕⊝⊝⊝ Very low^h,i,j
Postnatal depression	See comments		Not estimable	(0 studies)		No data reported this outcome in any of the included studies
Postnatal depression			Not estimable	(0 studies)
Development of subsequent type 2 diabetes mellitus	See comments		Not estimable	(0 studies)		No data reported this outcome in any of the included studies
Development of subsequent type 2 diabetes mellitus			Not estimable	(0 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 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
a. Downgraded (‐1) for serious limitations in study design: due to unclear risk of selection bias in two of the six included studies; five of the six included studies were at high risk of performance bias; two of the six included studies were at high risk of detection bias; one study was at high risk of attrition bias. b. Downgraded (‐1) for serious inconsistency; considerable heterogeneity, possible due to different study populations. c. Downgraded (‐1) for serious indirectness; only one of the included studies was conducted outside Italy, and the Italian studies only included white women, the generalisability of findings is limited. d. Downgraded (‐1) for serious limitations in study design: all studies were at high risk of performance bias; one study was at high risk of detection bias. e. Downgraded (‐1) for serious imprecision; evidence of imprecision with wide confidence intervals crossing the line of no effect. f. Downgraded (‐1) for serious limitations in study design: all studies were at high risk of performance bias; two studies were at high risk of detection bias. g. Downgraded (‐1) for serious limitations in study design: all studies were at high risk of performance bias. One study was at high risk of detection bias, and insufficient evidence to judge detection bias and subsequent judgement of unclear risk of bias. Due to insufficient evidence to judge allocation concealment in two studies and subsequent judgement of unclear risk of bias. Due to insufficient evidence to judge attrition bias in two studies and subsequent judgement of unclear risk of bias. h. Downgraded (‐1) for serious limitations in study design: the study was at high risk of performance bias and detection bias for lack of blinding. i. Downgraded (‐1) for serious Indirectness: only one study conducted in Ireland reported this outcome. j. Downgraded (‐1) for serious imprecision: wide confidence intervals with very low event rates.

Summary of findings 1. Myo‐inositol for preventing gestational diabetes: maternal outcomes

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Summary of findings 2. Myo‐inositol for preventing gestational diabetes: infant, child and adult outcomes

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Antenatal supplementation with myo‐inositol for preventing gestational diabetes
Patient or population: infants of pregnant women Setting: hospital Intervention: myo‐inositol Comparison: folic acid or placebo
Outcomes	Risk with control	Risk with myo‐inositol	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Large‐for‐gestational age	Study population		RR 1.40 (0.65 to 3.02)	234 (1 RCT)	⊕⊕⊝⊝ Low^a,b
Large‐for‐gestational age	85 per 1000	120 per 1000 (56 to 258)	RR 1.40 (0.65 to 3.02)	234 (1 RCT)	⊕⊕⊝⊝ Low^a,b
Perinatal mortality (stillbirth and neonatal mortality)	See comments		Not estimable	(0 studies)		No data reported this outcome in any of the included studies
Perinatal mortality (stillbirth and neonatal mortality)			Not estimable	(0 studies)
Composite of serious neonatal outcomes	See comments		not estimable	(0 studies)		No data reported this outcome in any of the included studies
Composite of serious neonatal outcomes			not estimable	(0 studies)
Neonatal hypoglycaemia	Study population		RR 3.07 (0.90 to 10.52)	671 (4 RCTs)	⊕⊝⊝⊝ Very low^c,d,e
Neonatal hypoglycaemia	9 per 1,000	27 per 1000 (8 to 91)	RR 3.07 (0.90 to 10.52)	671 (4 RCTs)	⊕⊝⊝⊝ Very low^c,d,e
Adiposity	See comments		not estimable	(0 studies)		No data reported this outcome in any of the included studies
Adiposity			not estimable	(0 studies)
Diabetes	See comments		not estimable	(0 studies)		No data reported this outcome in any of the included studies
Diabetes			not estimable	(0 studies)
Neurosensory disability	See comments		not estimable	(0 studies)		No data reported this outcome in any of the included studies
Neurosensory disability			not estimable	(0 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 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
a. Downgraded (‐1) for serious limitations in study design: the study was at high risk of performance bias and detection bias for lack of blinding. b. Downgraded (‐1) for serious indirectness: only one study conducted in Ireland reported this outcome. c. Downgraded (‐1) for serious limitations in study design: all studies were at high risk of performance bias; one study was at high risk of detection bias. d. Downgraded (‐1) for serious indirectness: only one of the included studies was conducted outside Italy, and the Italian studies only included Caucasian women. Thus, the generalisability of findings is limited. e. Downgraded (‐1) for serious imprecision: evidence of imprecision with wide confidence intervals crossing the line of no effect.

Summary of findings 2. Myo‐inositol for preventing gestational diabetes: infant, child and adult outcomes

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Comparison 1. Myo‐inositol versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Gestational diabetes mellitus Show forest plot	6	1140	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.31, 0.90]

1.2 Fasting OGTT Show forest plot	5	1071	Mean Difference (IV, Fixed, 95% CI)	‐0.14 [‐0.21, ‐0.07]

1.3 One hour OGTT Show forest plot	5	1071	Mean Difference (IV, Fixed, 95% CI)	‐0.34 [‐0.55, ‐0.14]

1.4 Two hour OGTT Show forest plot	5	1071	Mean Difference (IV, Random, 95% CI)	‐0.38 [‐0.77, 0.01]

1.5 Hypertensive disorders of pregnancy Show forest plot	5	1052	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.19, 0.61]

1.6 Large‐for‐gestational‐age Show forest plot	1	234	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [0.65, 3.02]

1.7 Caesarean section Show forest plot	4	829	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.77, 1.07]

1.8 Weight gain during pregnancy Show forest plot	4	831	Mean Difference (IV, Random, 95% CI)	‐0.25 [‐1.26, 0.76]

1.9 Relevant biomarker changes associated with the intervention Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.9.1 Total cholesterol	3	340	Mean Difference (IV, Fixed, 95% CI)	‐29.57 [‐32.80, ‐26.33]
1.9.2 Low density lipoprotein	3	340	Mean Difference (IV, Fixed, 95% CI)	‐22.43 [‐25.86, ‐19.00]
1.9.3 High density lipoprotein	3	340	Mean Difference (IV, Fixed, 95% CI)	‐1.46 [‐2.72, ‐0.20]
1.9.4 Triglycerides	3	340	Mean Difference (IV, Fixed, 95% CI)	‐24.92 [‐27.82, ‐22.02]
1.10 Perineal trauma Show forest plot	1	234	Risk Ratio (M‐H, Fixed, 95% CI)	4.00 [0.45, 35.25]

1.11 Postpartum haemorrhage Show forest plot	1	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.31, 1.42]

1.12 Adherence to intervention Show forest plot	1	240	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.84, 1.16]

1.13 Supplementary insulin Show forest plot	3	595	Risk Ratio (M‐H, Fixed, 95% CI)	0.50 [0.17, 1.52]

1.14 Gestational age at birth Show forest plot	4	829	Mean Difference (IV, Random, 95% CI)	3.69 [‐1.48, 8.86]

1.15 Preterm birth (less than 37 weeks' gestation) Show forest plot	4	829	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.17, 0.70]

1.16 Macrosomia Show forest plot	4	829	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.16, 1.96]

1.17 Birthweight Show forest plot	4	829	Mean Difference (IV, Random, 95% CI)	‐8.65 [‐140.36, 123.07]

1.18 Shoulder dystocia Show forest plot	4	829	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.15, 13.54]

1.19 Respiratory distress syndrome Show forest plot	2	431	Risk Ratio (M‐H, Fixed, 95% CI)	1.49 [0.25, 8.85]

1.20 Neonatal hypoglycaemia Show forest plot	4	671	Risk Ratio (M‐H, Fixed, 95% CI)	3.07 [0.90, 10.52]

1.21 Small‐for‐gestational‐age Show forest plot	1	234	Risk Ratio (M‐H, Fixed, 95% CI)	2.33 [0.62, 8.80]

1.22 Neonatal hyperbilirubinaemia Show forest plot	1	234	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.05, 1.15]

1.23 Admission to neonatal intensive care unit or special care baby unit Show forest plot	2	435	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.14, 1.18]

Comparison 1. Myo‐inositol versus control

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