To assess whether in women with early PPROM tocolytics improve perinatal outcome.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure will be a composite neonatal morbidity status,
including perinatal death, chronic lung disease, severe intraventricular
haemorrhage grade 3 and 4, periventricular leucomalacia more than grade 1,
proven sepsis and necrotising enterocolitis.
Secondary outcome
Secondary outcome will be birth weight, gestational age at delivery, number of
days on additional oxygen, days on supported ventilation, number of days in
intensive care and total days in hospital until 3 months corrected age.
Background summary
In the Netherlands, preterm birth is responsible for over 80% of all neonatal
deaths and 50% of childhood neurological morbidities. 25 to 40% of the cases of
preterm birth start with premature preterm rupture of membranes (PPROM). This
makes PPROM, in combination with preterm labor (contractions before 37 weeks'
gestation) the leading identifiable cause for preterm delivery. PPROM itself
complicates in approximately 3 to 5% of all pregnancies. At present, in women
with PPROM tocolysis is sometimes applied, but there is no uniform guideline.
It is not clear if tocolytic treatment is effective in patients with PPROM and,
if so, whether the effects justify the additional costs of this treatment.
Study objective
To assess whether in women with early PPROM tocolytics improve perinatal
outcome.
Study design
Randomized double-blind placebo-controlled trial performed in all ten perinatal
centers in The Netherlands.
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).
Study burden and risks
Participation in the study will not lay an extra burden on the patients. This
treatment is used in practice these days, but the effectivity is uncertain.
There is a small risk of hypotension as a result of the medication. A possible
benefit for the patient is that if tocolysis proves to be effective, perinatal
outcome for patients on active study medication will be better.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
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
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-000174-66-NL |
| CCMO | NL35416.018.11 |