No registrations found.
ID
Source
Brief title
Health condition
Premature Preterm Rupture Of Membranes, Nifedipine, Tocolysis
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Neonatal mortality;
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
1. Gestational age at delivery;
2. Birth weight;
3. Number of days in neonatal intensive care;
4. Number of days on supported ventilation;
5. Number of days on additional oxygen;
6. Total days in hospital until 3 months corrected age;
7. Economic analysis.
Background summary
Rationale:
At present, women with premature preterm rupture of membranes (PPROM) are in some cases treated with tocolytics and in other cases not. It is unclear whether treatment with tocolytics should take place in order to delay labor.
Objective:
To assess whether in women with early PPROM tocolytics improve perinatal outcome.
Study design:
Randomized placebo controlled trial.
Study population:
Women with PPROM between 24+0/7 and 33+6/7 weeks gestational age.
Intervention:
Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes).
Main study parameters/endpoints:
Primary outcome is composite neonatal morbidity status, i.e. severe morbidity and death at 6 months. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days in hospital.
Study objective
The aim of the study is to assess whether in women with early PPROM tocolytics improve perinatal outcome.
Study design
In view of the relatively small sample size, the fact that both treatments are already applied and are both mentioned in the Dutch guidelines, an interim analysis is not planned.
Intervention
Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes).
Dept Obstetrics and Gynaecology
T.S. Lange, de
Amsterdam
The Netherlands
apostel4@studies-obsgyn.nl
Dept Obstetrics and Gynaecology
T.S. Lange, de
Amsterdam
The Netherlands
apostel4@studies-obsgyn.nl
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;
3. Women with ruptured membranes longer than 72 hour;
4. Women having signs of chorioamnionitis or signs of intra uterine infection;
5. Women whose child has signs of fetal distress (abnormal CTG, abnormal biophysical profile);
6. Women with any contraindication for the use of nifedipine;
7. Having a maternal disease (hypertension, HELLP syndrome, preeclampsia or other) as reason for delivery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3211 |
| NTR-old | NTR3363 |
| Other | MEC AMC : 11/092 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |