Goldzieher 1964.
Methods | Unit of randomization: pregnancy
Method of randomization: sequentially numbered bottles. It is not clear who was responsible for the coding.
Timing of randomization: unclear
Blinding: yes (double)
Power calculation: no
Number of centers: 2 main centers 54 women randomized, 0 women excluded, 54 women analyzed Source of funding: Upjohn |
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Participants | Women who had either:
All women had to have a urinary pregnanediol of < 5 mg/d before 8 weeks' gestation and/or < 7 mg/d by 14 weeks' gestation. Age: not stated Location: USA |
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Interventions | 10 mg/d of oral medroxyprogesterone Control: placebo Duration: not stated |
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Outcomes | Miscarriage Preterm delivery | |
Notes | Dates of study: not stated Funding sources: supported by a grant from the Upjohn Company, Kalamazoo, Michigan 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 numbered bottles. Code not broken until end of trial |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
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 outcome data |
Selective reporting (reporting bias) | Low risk | None |
Other bias | Low risk | None apparent |