D'Anna 2013.
Study characteristics | ||
Methods | Study type: parallel RCT | |
Participants | 220 women from Italy Inclusion criteria: first‐degree relative (mother, father or both) affected by type 2 diabetes, pre‐pregnancy BMI < 30 kg/m2, fasting plasma glucose < 126 mg/dL and random glycaemia < 200 mg/dL, singleton pregnancy, Caucasian. Women were 12 to 13 weeks' gestation at study entry. Exclusion criteria: pre‐pregnancy BMI ≥ 30 kg/m2, previous gestational diabetes, pre‐gestational diabetes, first trimester glycosuria, first‐degree relative (mother or father) not affected by type 2 diabetes, fasting plasma glucose ≥ 126 mg/dL or random glycaemia ≥ 200 mg/dL, twin pregnancy, associated therapy with corticosteroids, PCOS. Location: Department of Gynecology and Obstetrics, University of Messina, Messina, Italy Timeframe: 2010 to 2012 |
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Interventions | Intervention: 4 g myo‐inositol plus 400 mcg folic acid daily (2 g myo‐inositol plus 200 mcg folic acid twice a day) (N = 110) Duration of myo‐inositol supplementation: from trial entry until the end of pregnancy Comparison: 400 mcg folic acid daily (200 mcg folic acid twice a day) as placebo (N = 110) |
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Outcomes |
Maternal: incidence of gestational diabetes, gestational hypertension, caesarean section Criteria used to diagnose gestational diabetes: IADPSG Infant: fetal macrosomia (> 4000 g), preterm birth, shoulder dystocia, neonatal hypoglycaemia, respiratory distress syndrome |
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Notes |
Sample size calculation: not stated Intention‐to‐treat analysis: yes (carried out but not reported) Losses to follow‐up: 11 women in the intervention group and 12 in the comparison group Funding source: none, the women bought the supplement on their own Conflict of interest: none reported Further information was received following email contact with the authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer randomization was used" |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial. Blinding not carried out |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Primary outcome of incidence of gestational diabetes diagnosed by blood test so blinding unlikely to impact assessment of this outcome. However, other secondary outcomes are more subjective. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall 10% loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcome measures were reported. |
Other bias | Low risk | Intention‐to‐treat analysis was carried out on the available data. |