Cetingoz 2011.
Study characteristics | ||
Methods | Randomised placebo‐controlled double‐blind study Department of Obstetrics and Gynecology, Istanbul, Turkey From December 2004 to February 2007 |
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Participants | 170 women recruited (n = 160 randomised): 84 allocated to intervention and 76 allocated to placebo. Inclusion criteria: high‐risk pregnant women: twin pregnancies; pregnancies with at least 1 spontaneous preterm birth; uterine malformation; randomisation at 24 weeks' gestation Exclusion criteria: not stated. 2 abortions, 7 deliveries between 20 ‐ 24 weeks and 1 woman with prophylactic cerclage were excluded |
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Interventions | Intervention group: micronised progesterone (100 mg) administered daily by vaginal suppository between 24 and 34 weeks of gestation Control/Comparison group: placebo (100 mg) administered daily by vaginal suppository between 24 and 34 weeks of gestation | |
Outcomes | Delivery < 37 weeks Delivery < 34 weeks Preterm labour admission NICU admission Neonatal death | |
Notes | Funding sources: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random‐number list ‐ “Patients were allocated according to randomised number table”. |
Allocation concealment (selection bias) | Low risk | Random‐number list generated centrally by research hospital pharmacy |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “The participating women, their caregivers, and the research personnel were unaware of the woman’s study‐group assignments.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treatment assignment blinded until delivery of last pregnant woman |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 160 women were randomised ‐ 10 lost during follow‐up, 6 from the placebo group and 4 from intervention group 150 women analysed. |
Selective reporting (reporting bias) | High risk | Trial was not registered and no published protocol |
Other bias | Low risk | Sample size calculation met. No baseline group differences. ITT analysis undertaken Ethics approval obtained |