Reijnders 1988.
Methods | Unit of randomization: pregnancy
Method of randomization: sequentially‐coded ampules supplied by the drug company
Timing of randomization: 6‐7 weeks' gestation
Blinding: yes (double)
Number of centers: not stated
Power calculation: yes (80% with 40 in each group) 64 women randomized, 0 women excluded, 64 women analyzed Source of funding: Schering |
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Participants | Women who fell into ≥ 1 of the following criteria:
Evidence of a viable fetus at 6 weeks of pregnancy was required to be enrolled in the trial Age: not stated Location: Netherlands Timing and duration: not stated |
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Interventions | 500 mg/week IM of hydroxyprogesterone caproate Control: placebo Duration: from 7 weeks' gestation to 12 weeks' gestation |
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Outcomes | Miscarriage Preterm delivery | |
Notes | Impossible to tell which were results for the women with recurrent pregnancy loss Dates of study: not stated Funding sources: Schering Nederland BV for providing 17‐OHP‐C and for financial support Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Sequentially coded ampules supplied by central location |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not specifically stated but likely blinded and unlikely that knowledge of assignment would influence outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | None |
Other bias | Low risk | None |