Assessment of Perinatal Outcome after Sustained Tocolysis in Early Labour (APOSTEL II)

Phase 3

• Conditions: threatened preterm labour; 10010273

• Registration Number: NL-OMON30860
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Women with a gestational age between 24+0 and 31+6 weeks who are spontaneously in labour, and who have been treated for 48 hours with tocolytics.

Exclusion Criteria

Women with signs of intra-uterine infection, women whose child has signs of fetal distress (abnormal CTG or biophysical profile) or major congenital malformation and women with any contraindication for the use of nifedipine or having a maternal disease (severe hypertension, HELLP syndrome, preeclampsia or other) or other reason for delivery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome measure will be a composite neonatal morbidity status,<br /><br>including perinatal death, chronic lung disease (CLD) and severe respiratory<br /><br>distress syndrome (IRDS), intra ventricular hemorrhage (IVH) grade 3 and 4,<br /><br>periventricular leukomalacia (PVL) and necrotizing enterocolitis (NEC) at the<br /><br>calculated term date. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be gestational age at delivery, number of days in NICU,<br /><br>and total days in hospital and costs.</p><br>