Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV)

• Conditions: Premature preterm rupture of membranes; MedDRA version: 14.1Level: PTClassification code 10036600Term: Premature labourSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-000174-66-NL
• Lead Sponsor: Academic Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

All women with a gestational age between 24+0/7 and 33+6/7 weeks with ruptured membranes without other signs of active labour are eligible for the trial.
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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women with = 3 contractions per 10 minutes, woman with symptoms justifying start of tocolysis, women with ruptured membranes longer than 72 hour, women having signs of chorioamnionitis or signs of intra uterine infection, women whose child has signs of fetal distress (abnormal CTG, abnormal biophysical profile) or women with any contraindication for the use of nifedipine or having a maternal disease (hypertension, HELLP syndrome, preeclampsia or other) as reason for delivery.

Study & Design

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