APOSTEL III.

Trial name or title	APOSTEL III
Methods	Randomised controlled trial.
Participants	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, ≥ 3 contractions per 30 minutes, and 1 of the following: 1. cervical length of ≤ 10 mm or; 2. cervical length of 11‐30 mm and a positive Fibronectin test or; 3. ruptured amniotic membranes.
Interventions	ORA group: atosiban. Bolus dose 6.75 mg (i.v.), followed by 18 mg/h for 3 h (i.v.) then 6 mg/h for 45 h. Control group: nifedipine. Bolus dose of 20 mg orally, followed by 20 mg every 6 h for 47 h.
Outcomes	Primary outcome: 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.
Starting date	21 June 2011
Contact information	Dr K Heida Dept. of Obstetrics UMC Utrecht Utrecht The Netherlands
Notes	NTR:2947

h: hour
 i.v.: intravenous
 ORA: oxytocin receptor antagonists