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. 2019 Nov 20;2019(11):CD003511. doi: 10.1002/14651858.CD003511.pub5

Reijnders 1988.

Methods Unit of randomization: pregnancy
 Method of randomization: sequentially‐coded ampules supplied by the drug company
 Timing of randomization: 6‐7 weeks' gestation
 Blinding: yes (double)
 Number of centers: not stated
 Power calculation: yes (80% with 40 in each group)
64 women randomized, 0 women excluded, 64 women analyzed
Source of funding: Schering
Participants Women who fell into ≥ 1 of the following criteria:
  • pregnancy after ovulation induction

  • ≥ 2 previous miscarriages

  • period of infertility for > 12 months


Evidence of a viable fetus at 6 weeks of pregnancy was required to be enrolled in the trial
Age: not stated
Location: Netherlands
 Timing and duration: not stated
Interventions 500 mg/week IM of hydroxyprogesterone caproate
Control: placebo
Duration: from 7 weeks' gestation to 12 weeks' gestation
Outcomes Miscarriage
 Preterm delivery
Notes Impossible to tell which were results for the women with recurrent pregnancy loss
Dates of study: not stated
Funding sources: Schering Nederland BV for providing 17‐OHP‐C and for financial support
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) Low risk Sequentially coded ampules supplied by central location
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not specifically stated but likely blinded and 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