Methods | Unit of randomization: pregnancy Method of randomization: unclear Timing of randomization: before the 13th week of gestation Blinding: single Power calculation: no, listed as pilot study Number of centers: 1 ‐ tertiary infertility care unit in India 101 women randomized 2 women excluded 133 women analyzed (added controls without miscarriage history) Source of funding: not stated |
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Participants | Women with ≥ 3 miscarriages in the first trimester (up to 12 weeks' gestation) followed by a spontaneous conception confirmed by viable fetus on ultrasound Exclusions: abnormal thyroid, prolactin, or any other medication in the last 3 months. Also excluded if there was an apparent cause of miscarriages by multiple lab and chromosomal testing. Also excluded luteal phase defects diagnosed by midluteal serum progesterone. Age: 23‐40 years Location: India Timing and duration: taken up to 12 weeks |
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Interventions | Intervention: 10 mg oral dydrogesterone twice daily (50 women) or 100 mg micronized vaginal progesterone three times daily (51 women), taken up to 12 weeks Control: women without a history of miscarriage (32 women) |
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Outcomes | Uterine doppler blood flow parameters, ongoing clinical pregnancy (at least 1 viable fetus at 28 weeks' gestation), viable delivery, miscarriage rates | |
Notes | Emailed contact author to ask about "ongoing pregnancy" group. if still pregnant at time of analysis, only able to utilize miscarriage data Dates of study: not stated Funding sources: "no financial support received" Declarations of interest: trial authors report "no conflicts of interest" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study co‐ordinator did a "simple randomization" |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed envelopes prepared by study co‐ordinator |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were not blinded due to different routes of administration but study personnel were "unaware of the type of protocol being used" and considered single‐blinded but unlikely that knowledge of assignment would influence outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study personnel unaware of protocol |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 women excluded from analysis for adequate reasons |
Selective reporting (reporting bias) | Low risk | Reported on outcomes collected |
Other bias | Unclear risk | "ongoing pregnancy" group still pregnant at analysis so could not determine outcome for them other than that they did not have a miscarriage |