Methods | Unit of randomization: pregnancy Method of randomization: day of week attending clinic Timing of randomization: presentation for new pregnancy Blinding: unclear Power calculation: no Number of centers: 1 180 women randomized, 0 exclusions, 180 women analyzed Source of funding: not stated |
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Participants | Women (< 35 years old) with ≥ 3 consecutive unexplained abortions with same husband with a new pregnancy Age: treatment 22% age 20‐24 years, 36% age 25‐29 years, 41.5% age 30‐34 years, control: 21% age 20‐24 years, 48% age 25‐29 years, 31% age 30‐34 years Location: Jordan Timing and duration: 1994‐2000 |
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Interventions | 10 mg oral dydrogesterone, twice daily. 5000 IU IM hCG every 4 days, or no treatment Control: no treatment Duration: until miscarriage or 12th gestational week |
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Outcomes | Miscarriage, preterm delivery, fetal malformations, perinatal death (not analyzed in review: hospitalization for vaginal bleeding) | |
Notes | Dates of study: 1994‐2000 Funding sources: not stated Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Allocation by day of the week |
Allocation concealment (selection bias) | High risk | Allocation by day of the week |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not stated 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 | Low risk | Does not appear to be incomplete data |
Selective reporting (reporting bias) | Low risk | None noted |
Other bias | Low risk | None noted |