D'Anna 2013.
Methods | Type of study: parallel, randomised controlled trial. | |
Participants | 220 women from Italy. Eligibility criteria: first‐degree relative (mother, father or both) affected by type 2 diabetes, prepregnancy BMI < 30 kg/m2, fasting plasma glucose < 126 mg/dL and random glycaemia < 200 mg/dL, singleton pregnancy, Caucasian. Women were 12‐13 weeks' gestation at trial entry. Exclusion criteria: pre‐pregnancy BMI ≥ 30 kg/m2, previous GDM, 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, polycystic ovarian syndrome. Location: Department of Gynecology and Obstetrics, University of Messina, Messina, Italy. Timeframe: 2010‐2012. |
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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 GDM, gestational hypertension, caesarean section. Criteria used to diagnose GDM: 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 of funding not stated. |
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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 GDM 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 on. |
Other bias | Unclear risk | Intention‐to‐ treat analysis was carried out on the available data, but was not reported in the manuscript. |