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.
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2017-001007-72-NL

Lead Sponsor: Amsterdam UMC location AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 760

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 or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test
- Ruptured amniotic membranes

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 760
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
- 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 late preterm birth (30 to 34 weeks) is (cost-) 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 Dutch 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.

Secondary Outcome Measures