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. 2018 Oct 9;2018(10):CD003511. doi: 10.1002/14651858.CD003511.pub4
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
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
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
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
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