ifedipine versus Atosiban in the treatment of threatened preterm labour: APOSTEL III

Phase 4

Completed

• Conditions: 10010273; Preterm delivery; threatened preterm birth

• Registration Number: NL-OMON38113
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Women * 18 years old with a singleton pregnancy with a gestational age of 24-34 weeks in threatened preterm labour, as defined by:
* Uterine contractions, at least 3 contractions per 30 minutes and a cervical length of * 10 mm ór
* Uterine contractions, at least 3 contractions per 30 minutes and a cervical length of 11-30 mm ánd a positive Fibronectin test ór
* Ruptured amniotic membranes

Exclusion Criteria

- Vaginal bleeding
- Cerclage
- Cervical dilatation > 30 mm
- Previous treatment for preterm contractions
- Hypertension / anti-hypertensive agent
- Myocardial infarction (<1 month)
- Unstable angina pectoris

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study will be a composite for poor neonatal outcome.<br /><br>This outcome will include chronic lung disease, periventricular leucomalacia ><br /><br>grade 1, intraventricular haemorrhage > grade 2, NEC > stage 1, proven sepsis<br /><br>and in-hospital death. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be time to delivery, gestational age at delivery,<br /><br>number of days on ventilation support, number of days in NICU, total days of<br /><br>the baby alive outside the hospital counted from a gestational age of 37 weeks<br /><br>and maternal side effects.</p><br>