Malvasi 2014.
| Methods | Parallel, randomised controlled trial. | |
| Participants | 65 pregnant women from Italy. Eligibility criteria: healthy pregnant women, aged between 30‐40, between 13 and 24 weeks' gestation, BMI between 25‐30 kg/m2. Exclusion criteria: diabetes mellitus, cardiovascular disease, chronic hypertension, autoimmune disease, dysthyroidism. Location: Bari, Italy. Timeframe: January to December 2012. |
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| Interventions | Intervention: a combination of 2000 mg myo‐inositol, 400 mg d‐chiro‐inositol, 400 mcg folic acid, 10 mg manganese. Duration of myo‐inositol supplementation: 60 days. Comparison: not stated. |
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| Outcomes | Maternal: total cholesterol, LDL, HDL, blood glucose. Criteria used to diagnose GDM: not stated. Infant: not stated. |
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| Notes | Sample size calculation not stated. Funding not stated. The authors did not report any potential financial conflicts of interest. Authors were contacted and provided further information. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation sequence was generated by a random number table. |
| Allocation concealment (selection bias) | Low risk | Allocation was controlled by an independent statistician who assigned numbered patients to groups using sealed numbered containers. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were blinded. Clinicians were aware of treatment allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 65 women were initially enrolled, 17 of which were excluded – 6 did not meet inclusion criteria, 4 refused to participate, 7 left the study spontaneously. Analysis was conducted on the remaining 48 women. |
| Selective reporting (reporting bias) | Unclear risk | All pre‐specified outcomes are reported on (total cholesterol, LDL, HDL, blood glucose). No other maternal, pregnancy or neonatal outcomes are specified or reported. |
| Other bias | Low risk | Appears free of other bias. The authors do not report any potential conflicts of interest. |
BMI: body mass index GDM: gestational diabetes mellitus g: grams HbA1c: Glycated haemoglobin HDL: high density lipoprotein IADPSG: International Association of Diabetes and Pregnancy Study Groups kg/m2: kilograms per metre squared LDL: low density lipoprotein mcg: micrograms mg/dL: milligrams per decilitre OGTT: oral glucose tolerance test