ifedipine versus Atosiban in the treatment of threatened preterm labour: APOSTEL III.
Completed
- Conditions
- TocolysisAtosibanNifedipinePreterm LabourTocolyseVroeggeboorte
- Registration Number
- NL-OMON20652
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Women ≥ 18 years old with a singleton pregnancy with a gestational age of 25-34 weeks in threatened preterm labour, as defined by:
Uterine contractions, at least 3 contractions per 30 minutes, and one of the following:
Exclusion Criteria
1. Vaginal bleeding;
2. Cerclage;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be a composite poor neonatal outcome, including broncho pulmonary dysplasia (BPD), periventricular leucomalacia (PVL) > grade 1, intracerebral haemorrhage > grade 2, necrotising enterocolitis (NEC) > stage 1, proven sepsis and in-hospital death.
- Secondary Outcome Measures
Name Time Method Secondary outcomes will be time to delivery, gestational age at delivery, number of days on ventilation support, in NICU, total days of the baby alive outside the hospital counted from a gestational age of 37 weeks and maternal side effects.