Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour: Nifedipine versus placebo in the treatment of preterm premature rupture of membranes.

Suspended

Conditions: Premature Preterm Rupture Of Membranes, Nifedipine, Tocolysis

Registration Number: NL-OMON27174

Lead Sponsor: Academic Medical Center (AMC)

Brief Summary: ijman, Tobias AJ, et al. "Nifedipine versus placebo in the treatment of preterm prelabor rupture of membranes: a randomized controlled trial: Assessment of perinatal outcome by use of tocolysis in early labor—APOSTEL IV trial." European Journal of Obstetrics & Gynecology and Reproductive Biology 205 (2016): 79-84.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

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.

Exclusion Criteria

1. Women with ≥3 contractions per 10 minutes;

2. Woman with symptoms justifying start of tocolysis;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Neonatal mortality;<br /><br>2. Composite neonatal morbidity (ie. chronic lung disease, severe intraventricular hemorrhage more than grade 2, periventricular leucomalacia more than grade 1, proven sepsis, necrotising enterocolitis).

Secondary Outcome Measures

Name	Time	Method
1. Gestational age at delivery;<br /><br>2. Birth weight;<br /><br>3. Number of days in neonatal intensive care;<br /><br>4. Number of days on supported ventilation;<br /><br>5. Number of days on additional oxygen;<br /><br>6. Total days in hospital until 3 months corrected age;<br /><br>7. Economic analysis.