Overview

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

Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators:
Amphia Hospital
Deventer Ziekenhuis
Diakonessenhuis, Utrecht
Erasmus Medical Center
Flevoziekenhuis
Franciscus Gasthuis
Gelre Hospitals
Groene Hart Ziekenhuis
Haaglanden Medical Centre
Isala
Leiden University Medical Center
Maastricht University Medical Center
Martini Hospital Groningen
Maxima Medical Center
Medical Centre Leeuwarden
Medisch Spectrum Twente
National Maternity Hospital, Ireland
Nottingham University Hospitals NHS Trust
OLVG
Radboud University Medical Center
Rijnstate Hospital
Spaarne Gasthuis
ST. Antonius hospital Nieuwegein
Tergooi Hospital
UMC Utrecht
University Medical Center Groningen
Ziekenhuisgroep Twente
ZonMw: The Netherlands Organisation for Health Research and Development
Zuyderland Medical Centre
Treatments:
Atosiban
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