Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth (APOSTEL 8)
Preterm Birth
About this trial
This is an interventional treatment trial for Preterm Birth focused on measuring preterm birth, threatened preterm birth, preterm labour, atosiban, adverse neonatal outcome
Eligibility Criteria
Inclusion Criteria: Women ≥ 18 years Singleton or twin pregnancy Gestational age between 30 0/7 and 33 6/7 weeks Threatened preterm birth defined by regular uterine contractions, AND one of the following: Cervical length of < 15 mm OR Cervical length of 15-30 mm and a positive Fibronectine test (≥ 50 ng/mL) OR In case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test OR Ruptured amniotic membranes Exclusion Criteria: Previous treatment for threatened preterm birth with corticosteroids in current pregnancy Contra indication for tocolysis Signs of fetal distress Signs of intra uterine infection
Sites / Locations
- Amsterdam University Medical Centres, location AMCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
atosiban
placebo
Atosiban: bolus injection of 6.75 mg/0.9 ml atosiban in one minute followed by a continuous infusion of 18 mg/hour (=24ml/hour) for 3 hours followed by a continuous infusion of 6 mg/hour (=8 ml/hour) for the remaining 45 hours.
Placebo: injection of 0.9 ml saline in one minute followed by a saline infusion for 3 hours (24 ml/hour) followed by a continuous infusion (8 ml/hour) for the remaining 45 hours.