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. 2018 Jul 24;2018(7):CD010564. doi: 10.1002/14651858.CD010564.pub2

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
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
Outcomes
  1. Pre‐eclampsia

  2. GDM

  3. Birthweight

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
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