Klopper 1965.
Methods | Unit of randomization: pregnancy
Method of randomization: random schedules generated by a statistician
Timing of randomization: before 10 weeks' gestation
Power calculation: no
Blinding: yes (double)
Number of centers: 2 33 women randomized, 33 women analyzed Source of funding: not stated |
|
Participants | Women who had ≥ 2 miscarriages, no pregnancy beyond 28 weeks' gestation, were < 10 weeks into the current pregnancy and with no other obvious causes of miscarriage | |
Interventions | 50 mg twice daily of oral cyclopentyl enol ether of progesterone Control: placebo Duration: not stated |
|
Outcomes | Miscarriage | |
Notes | Dates of study: not stated Funding sources: somewhat unclear although the authors acknowledge "the firm of Vister who supplied the steroid and allowed their product to be subjected to a much more rigorous test than is usual in this field." Declarations of interest: not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random schedules generated by statistician |
Allocation concealment (selection bias) | Unclear risk | Given according to a random schedule |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded design ‐ neither participants nor physician knew which of the 2 they were getting. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not stated but likely blinded, but 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 |