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