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

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.

Conditions

• Preterm Birth

Interventions

DRUG

Atosiban

atosiban i.v. administred for 48 hours. The medication will be administered by a bolus injection of 6.75 mg/0.9 mL in 1 min followed by a continuous infusion of 18 mg/hour for 3 hours followed by a continuous infusion of 6 mg/hour for the remaining 45 hours.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• Deventer Ziekenhuis

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Flevoziekenhuis

  collaborator OTHER

• Franciscus Gasthuis

  collaborator OTHER

• Gelre Hospitals

  collaborator OTHER

• Groene Hart Ziekenhuis

  collaborator OTHER

• Isala

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Maxima Medical Center

  collaborator OTHER

• Frisius Medisch Centrum

  collaborator OTHER

• Haaglanden Medical Centre

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• OLVG

  collaborator NETWORK

• Radboud University Medical Center

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Spaarne Gasthuis

  collaborator OTHER

• Tergooi Hospital

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Ziekenhuisgroep Twente

  collaborator OTHER

• Zuyderland Medical Centre

  collaborator OTHER

• National Maternity Hospital, Ireland

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• Netherlands

Study Locations