Awwad 2015.
| Study characteristics | ||
| Methods | Single‐centred, controlled, double‐blind trial with randomisation into 1 of 2 parallel groups, with a treatment‐to‐placebo ratio of 2:1. The study took place in Beruit, Lebanon between September 2006 and December 2011 | |
| Participants | 293 women aged 18 years or more, with an ultrasound‐diagnosed twin pregnancy Exclusion criteria: ultrasonographically‐diagnosed fetal anomalies; elective cervical cerclage before 14 weeks' gestation; hypertension; diabetes; mellitus; asthma; history of deep vein thrombosis; history of hepatic disease or abnormal liver enzymes; pre‐existing renal disease or abnormal kidney function; and seizure disorders |
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| Interventions |
Intervention group: participants received weekly injections of 250 mg 17‐hydroxyprogesterone caproate from 16 ‐ 20 weeks to 36 weeks of gestation Control group: participants received weekly placebo from 16 ‐ 20 weeks to 36 weeks of gestation |
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| Outcomes |
Primary outcome: preterm birth prior to 37 weeks of gestation Secondary clinical outcomes measures included: early preterm birth (prior to 32 and 28 weeks of gestation); low birthweight < 2500 g or very low birthweight < 1500 g or extremely low birthweight < 1000 g; neonatal morbidity; perinatal mortality; and maternal morbidity. Neonatal morbidity defined as any of the following: respiratory distress syndrome; pneumonia; culture‐confirmed sepsis; intraventricular haemorrhage grade III or IV; necrotising enterocolitis; periventricular leukomalacia; retinopathy of prematurity; patent ductus arteriosus; seizures; and/or bronchopulmonary dysplasia. Maternal morbidity included any of the following maternal complications occurring during the course of pregnancy: gestational diabetes mellitus; hypertensive disorders; and preterm premature rupture of the membranes Safety outcome measures: local side effects and systemic adverse events |
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| Notes | Funding sources: This study was funded by a grant from the Medical Practice Plan at the American University of Beirut, Beirut, Lebanon (principal investigator: Anwar H. Nassar, MD). Declarations of interest: none of the authors of this article had any conflicts of interest to report |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Permutated block randomisation method. Random sequence generation used random‐number tables |
| Allocation concealment (selection bias) | Low risk | Randomisation envelopes prepared in pharmacy department. Research assistants opened the next opaque envelope following recruitment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Treating doctors, investigators, ancillary personnel, and participants were all blinded to treatment assignment for the duration of the trial |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators and ancillary personnel blinded for the duration of the trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data reported for all randomised participants |
| Selective reporting (reporting bias) | Low risk | Stated outcomes reported |
| Other bias | Low risk | Sample size calculation met. ITT analysis undertaken. Ethics approval obtained |