Clinical trial

Atosiban Versus Placebo in the Treatment of Late Threatened Preterm Birth

Name

NL80-84800-98-41027

Description

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.

Trial arms

Trial start

2017-12-01

Estimated PCD

2023-07-01

Trial end

2024-07-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

atosiban, placebo

Other names:

Tractocile

Size

760

Primary endpoint

Adverse neonatal outcome

Up to 3 months corrected age

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International, multicenter, double blinded, placebo controlled RCT', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 760, 'type': 'ESTIMATED'}}

Updated at

2023-02-01

1 organization

1 product

1 indication

Organization

Academisch Medisch Centrum - Universiteit van Amsterdam

Product

Atosiban

Indication

premature birth