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Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labour


- candidate number3423
- NTR NumberNTR1336
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2008
- Secondary IDs 
- Public TitleAssessment of Perinatal Outcome with Sustained Tocolysis in Early Labour
- Scientific TitleAssessment of Perinatal Outcome with Sustained Tocolysis in Early Labour
- ACRONYMAPOSTEL II
- hypothesisReduction of perinatal mortality and severe perinatal morbidity with sustained tocolysis with nifedipine
- Healt Condition(s) or Problem(s) studiedPremature labour, Nifedipine, Tocolysis
- Inclusion criteria1. 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 criteria1. Signs of intrauterine infection
2. Signs of fetal distress
3. Maternal disease (ie. severe preeclampsia, HELLP syndrome)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-mrt-2008
- planned closingdate1-mei-2010
- Target number of participants400
- InterventionsPatients will be randomly allocated to nifedipine or placebo for 12 days
- 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
- TimepointsInterim analysis after inclusion of 200 patients
- Trial web sitewww.studies-obsgyn.nl/apostel2
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. C. Roos
- CONTACT for SCIENTIFIC QUERIESProf. Dr. F.K. Lotgering
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIt 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.
- Main changes (audit trail)
- RECORD3-jun-2008 - 3-jan-2011


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