No registrations found.
ID
Source
Brief title
Health condition
sustained tocolysis, premature labour
verlengde tocolyse, partus prematurus
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Neonatal mortality
- 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
- Gestational age at delivery
- Birth weight
- Number of days in neonatal intensive care
- Number of days on supported ventilation
- Number of days on additional oxygen
- Total days in hospital until 3 months corrected age
- Economic analysis
Background summary
It is evident that tocolysis with administration of corticosteroids is effective for 48 hours. At present, no unanimity exists among obstetricians, regarding benefits of sustained tocolysis.
Study design
Multicentre randomised placebo-controlled trial. The study will be performed within a consortium of ten perinatal centres, which are collaborating in several proposed studies. Study population: women with a gestational age between 26 and 32+2 weeks who have been treated with tocolysis and steroids for preterm birth for 48 hours are eligible for the trial.
Study objective
Reduction of perinatal mortality and severe perinatal morbidity with sustained tocolysis with nifedipine
Study design
Interim analysis after inclusion of 200 patients
Intervention
Patients will be randomly allocated to nifedipine or placebo for 12 days
Department of Obstetrics/ Gynaecology
Postbus 9101
C. Roos
Nijmegen 6500 HB
The Netherlands
c.roos@obgyn.umcn.nl
Department of Obstetrics/ Gynaecology
Postbus 9101
C. Roos
Nijmegen 6500 HB
The Netherlands
c.roos@obgyn.umcn.nl
Inclusion criteria
1. Gestational age between 26 and 32 weeks
2. Diagnosis of preterm birth
3. Treatment with tocolysis according to local protocol for 48 hours
4. Completed course of corticosteroids
Exclusion criteria
1. Signs of intrauterine infection
2. Signs of fetal distress
3. Maternal disease (ie. severe preeclampsia, HELLP syndrome)
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 | NL1289 |
| NTR-old | NTR1336 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |