Shearman 1963.
Methods | Unit of randomization: pregnancy
Method of randomization: unclear. The ampules were said to be coded but who coded these and how women were then allocated to the coded ampules is not stated.
Timing of randomization: before the 12th week of gestation
Blinding: yes (double)
Power calculation: no
Number of centers: 2 50 women randomized, 0 women excluded, 50 women analyzed Source of funding: preparations supplied by Schering |
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Participants | Women having had ≥ 2 consecutive abortions and who had low or falling pregnanediol levels Exclusions: women with uterine malformations Age: not stated Location: London, UK Duration and timing: not stated |
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Interventions | Up to 8 weeks' gestation: 250 mL/week IM hydroxyprogesterone
8‐11 weeks' gestation: 375 mL/week IM of 17‐a‐hydroxyprogesterone
12‐16 weeks' gestation: 500 mL/week IM of 17‐a‐hydroxyprogesterone
17‐20 weeks' gestation: 375 mg/week IM of 17‐a‐hydroxyprogesterone
21‐24 weeks' gestation: 250 mg/week IM of 17‐a‐hydroxyprogesterone Control: placebo |
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Outcomes | Miscarriage | |
Notes | Source of funding: preparations supplied by Schering Dates of study: not stated Funding sources: "the preparations used in this study were made available by Dr. Jurgen Friebel, Schering AG, Berlin" 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) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Solution A and B ‐ the "correct identity of these substances is not known to any person taking part in this study". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None |
Selective reporting (reporting bias) | Low risk | None |
Other bias | Low risk | None |