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. 2019 Nov 20;2019(11):CD003511. doi: 10.1002/14651858.CD003511.pub5

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
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
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
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
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