Reduction of perinatal mortality and severe perinatal morbidity with sustained tocolysis with nifedipine
ID
Bron
Verkorte titel
Aandoening
sustained tocolysis, premature labour
verlengde tocolyse, partus prematurus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Neonatal mortality<br>
- Composite neonatal morbidity (ie. chronic lung disease, severe intraventricular hemorrhage more than grade 2, periventricular leucomalacia more than grade 1, proven sepsis, necrotising enterocolitis)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Reduction of perinatal mortality and severe perinatal morbidity with sustained tocolysis with nifedipine
Onderzoeksopzet
Interim analysis after inclusion of 200 patients
Onderzoeksproduct en/of interventie
Patients will be randomly allocated to nifedipine or placebo for 12 days
Algemeen / deelnemers
Department of Obstetrics/ Gynaecology
Postbus 9101
C. Roos
Nijmegen 6500 HB
The Netherlands
c.roos@obgyn.umcn.nl
Wetenschappers
Department of Obstetrics/ Gynaecology
Postbus 9101
C. Roos
Nijmegen 6500 HB
The Netherlands
c.roos@obgyn.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Signs of intrauterine infection
2. Signs of fetal distress
3. Maternal disease (ie. severe preeclampsia, HELLP syndrome)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1289 |
| NTR-old | NTR1336 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |