Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth

Sex: Female

Ages: 18 Years – N/A

Healthy volunteers: 1

Phase: PHASE4

Enrollment: 760

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Eligibility Criteria

Inclusion Criteria:Women ≥ 18 yearsSingleton or twin pregnancyGestational age between 30 0/7 and 33 6/7 weeksThreatened preterm birth defined by regular uterine contractions, AND one of the following:Cervical length of < 15 mm ORCervical length of 15-30 mm and a positive Fibronectine test (≥ 50 ng/mL) ORIn case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test ORRuptured amniotic membranesExclusion Criteria:Previous treatment for threatened preterm birth with corticosteroids in current pregnancyContra indication for tocolysisSigns of fetal distressSigns of intra uterine infection

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05693688). StuddyBuddy aggregates publicly available trial information.