| Study characteristics |
| Methods |
2‐arm placebo‐controlled randomised trial. |
| Participants |
50 women were randomised in a hospital setting in Australia (date range not specified). The population comprised women with a history of 2 or more previous miscarriages. Exclusion criteria comprised women with persistently normal levels of pregnanediol. |
| 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 versus placebo. |
| Outcomes |
The study recorded the following outcomes relevant for this review: miscarriage. |
| Notes |
Contact with study authors for additional information: no. Additional data from authors: no. The study was funded by Schering AG. Declarations of interest were not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Sequence generation was not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study participants and caregivers were blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. However, this study was conducted before protocol registration became mandatory. |
| Other bias |
Low risk |
No other bias noted. |
