Agarwal 2016.
Methods | Unit of randomization: pregnancy
Method of randomization: unclear
Timing of randomization: unclear
Blinding: no
Power calculation: unknown
Number of centers: 1 90 women total enrolled; 30 randomized to progesterone, 30 to nothing, and 30 healthy controls; 300 women analyzed Source of funding: All India Institute of Medical Science |
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Participants | Women with a history of ≥ 2 consecutive miscarriages of unknown cause. Euthyroid Exclusion: history of repeated miscarriages of known cause Age: 21‐40 Location: India Timing and duration: August 2013‐unknown |
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Interventions | 200 mg oral micronized progesterone twice daily up until 16 weeks' gestation Control: no intervention Healthy control group |
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Outcomes | Cytokines, "perinatal outcome", occurrence of obstetric complications like ICP, pre‐eclampsia | |
Notes | Trial registry summary from Clinical Trials Registry ‐ India Dates of study: first enrollment 12 August 2013, completion date not specified Funding sources: All India Institute of Medical Sciences, New Dehli (government medical college) Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random number table." |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Only intervention group took drug but unlikely that knowledge of assignment would influence outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not stated but unlikely that knowledge of assignment would influence outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Only abstract results from trials registry |
Selective reporting (reporting bias) | Unclear risk | Unclear. Only abstract results available from trials registry |
Other bias | Unclear risk | Unclear. Only abstract results available from trials registry |