Suppression of contractions versus no suppression of contractions in the treatment of women giving birth too early.

Phase 1

• Conditions: eonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.; MedDRA version: 20.0Level: LLTClassification code 10014052Term: Early or threatened laborSystem Organ Class: 100000004868; MedDRA version: 20.1Level: LLTClassification code 10014053Term: Early or threatened labourSystem Organ Class: 100000004868; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2017-001007-72-GB
• Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1514

Inclusion Criteria

Women = 18 years old with a singleton or twin pregnancy with a gestational age between 30 0/7 and 33 6/7 weeks with 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 fFn test (= 50 ng/mL) or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test - Ruptured amniotic membranes

- Cervical length of < 15 mm
- Cervical length of 15-30 mm and a positive fFn test or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1514
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous treatment for threatened preterm birth with corticosteroids in current pregnancy.
- Contra indication for tocolysis
- Signs of fetal distress
- Signs of intra uterine infection
- Fetal chromosomal or severe congenital abnormalities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate if tocolysis with atosiban in preterm birth (30 to 34 weeks) is effective compared with placebo in improving neonatal morbidity and mortality.;Secondary Objective: Not applicable.;Primary end point(s): The primary outcome of the study will be a composite adverse perinatal outcome, consisting of bronchopulmonary dysplasia, periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis , retinopathy of prematurity > grade 2 or need for laser therapy, proven sepsis and perinatal death. Neonatal outcome will be assessed by neonatologists according definitions in the perinatal registry.<br>;Timepoint(s) of evaluation of this end point: Primary and secondary outcome measures will be registered from clinical patient data during hospitalization.