Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).

Phase 3

Recruiting

Conditions: theatened preterm labour
threatened preterm birth
10010273

Registration Number: NL-OMON54673

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 745

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a combined perinatal outcome of severe neonatal<br /><br>morbidity and perinatal mortality. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include birth <48 hours, time to delivery,<br /><br>gestational age at birth, admission to the Neonatal Intensive Care Unit (NICU),<br /><br>total number of days alive outside the hospital counted from 37 weeks gestation<br /><br>until corrected age of three months, maternal morbidity, adverse effects and<br /><br>cost. </p><br>