Malvasi 2014.
Study characteristics | ||
Methods | Study type: parallel RCT | |
Participants | 65 pregnant women from Italy Inclusion criteria: healthy pregnant women, aged between 30 to 40, between 13 and 24 weeks' gestation, BMI between 25 to 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: placebo (but not stated what placebo was) |
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Outcomes |
Maternal: total cholesterol, LDL, HDL, blood glucose Criteria used to diagnose gestational diabetes: not stated Infant: not stated |
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Notes |
Sample size calculation: not stated Funding source: not stated Conflicts 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 | 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 | Low risk | Outcome assessors were blinded. |
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) | Low 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. |