Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth (NCT05693688) | Clinical Trial Compass
CompletedPhase 4
Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth
Netherlands760 participantsStarted 2017-12-01
Plain-language summary
The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Adverse neonatal outcome
Timeframe: Up to 3 months corrected age
Trial details
NCT IDNCT05693688
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)