Kumar 2014.
Methods | Unit of randomization: pregnancy
Method of randomization: computer‐generated
Timing of randomization: early pregnancy
Blinding: yes
Power calculation: yes, needed 163 women in each group, planned to recruit 180 women to allow for loss to follow‐up
Number of centers: 2 antenatal clinics from one Center 180 women randomized, 826 women had results for primary outcome to analyze Source of funding: Indian Council of Medical Research |
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Participants | Women with history of idiopathic, ≥ 3 first‐trimester pregnancy losses and currently in the first trimester with a live pregnancy (preferably 2‐8 weeks' gestation). Exclusion: known cause of recurrent miscarriage, women who had taken an injection of hCG or hydroxyprogesterone Age: 18‐35 Location: India |
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Interventions | 20 mg dydrogesterone (taken as 2 x 10 mg tablets) from time of enrolment to 20 weeks Control: identical placebo Additional control group of women without a history of miscarriage who were age‐matched, healthy, pregnant women with at least 1 live birth |
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Outcomes | Cytokine profiles, pregnancy outcomes (from results section) ‐ miscarriage, EGA at delivery, preterm delivery, cesarean LBW, SGA | |
Notes | Dates of study: May 2010‐April 2013 Funding sources: Indian Council of Medical Research Declarations of interest: all trial authors state no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomization sequence generated by computers |
Allocation concealment (selection bias) | Low risk | Coded numbers on packets each containing 60 tablets of drug or placebo, sequentially distributed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Randomization unknown until after study completed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 12 lost to follow‐up with appropriate reasons |
Selective reporting (reporting bias) | Unclear risk | All outcomes recorded not stated in methods |
Other bias | Low risk | No other sources of bias identified |