PACTR201505001142202.
Methods | A prospective study (in the trial registration it is stated to be a RCT) El Shatby Hospital, Alexandria Egypt. Dates of enrolment not reported |
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Participants | 200 participants with BMI ≥ 35 kg/m2 and normal blood glucose, HbA1C and plasma insulin, in the early second trimester | |
Interventions |
Experimental intervention: metformin 500 mg twice a day versus placebo. 100 women enrolled Control intervention: placebo. 100 women enrolled |
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Outcomes |
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Notes | Minimal clinical outcomes No funding sources reported. Authors report no conflicts of interest. More information requested about all criteria for 'Risk of bias' assessment ‐ 15/03/2018 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were divided into two groups. |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants received "placebo", although it was not stated if the placebo had an identical appearance. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes were reported on all women enrolled in the study. |
Selective reporting (reporting bias) | High risk | 1 of 2 specified outcomes was not reported. |
Other bias | Low risk | None identified |