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‐Study flow diagram.
Figuras y tablas -
Figure 1

‐Study flow diagram.

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'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 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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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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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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Comparison 1 Myo‐inositol versus control, Outcome 1 Gestational diabetes mellitus.
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Analysis 1.1

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

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Comparison 1 Myo‐inositol versus control, Outcome 2 Fasting OGTT.
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Analysis 1.2

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

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

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

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

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

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

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

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Comparison 1 Myo‐inositol versus control, Outcome 6 Caesarean section.
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Analysis 1.6

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

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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.

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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.

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

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

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Comparison 1 Myo‐inositol versus control, Outcome 10 Supplementary insulin.
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Analysis 1.10

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

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

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

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

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

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

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

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Comparison 1 Myo‐inositol versus control, Outcome 14 Birthweight.
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Analysis 1.14

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

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Comparison 1 Myo‐inositol versus control, Outcome 15 Shoulder dystocia.
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Analysis 1.15

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

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

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

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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.

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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)
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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)
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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 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
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