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. 2019 Nov 20;2019(11):CD012024. doi: 10.1002/14651858.CD012024.pub3

Cetingoz 2011.

Study characteristics
Methods Randomised placebo‐controlled double‐blind study
Department of Obstetrics and Gynecology, Istanbul, Turkey
From December 2004 to February 2007
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
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
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