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Assessing the safety and effectiveness of tocolysis for preterm labour.


- candidate number27789
- NTR NumberNTR6646
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2017
- Secondary IDsNL61439.018.17 ABR
- Public TitleAssessing the safety and effectiveness of tocolysis for preterm labour.
- Scientific TitleAtosiban versus placebo in the treatment of threatened preterm birth: a randomised double blind trial.
- ACRONYMAPOSTEL VIII
- hypothesisThe aim of this study is to investigate if tocolysis with atosiban in threatened preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
- Healt Condition(s) or Problem(s) studiedPreterm birth
- Inclusion criteria- Woman ≥ 18 years old
- Singleton or twin pregnancy
- Gestational age between 30 0/7 and 33 6/7 weeks
- Threatened preterm birth defined by regular uterine contractions and one of the following:
- Ruptured amniotic membranes OR
- Cervical length of ≤ 15 mm OR
- Cervical length of 15-30 mm and a positive fibronectin test
- Exclusion criteria- Contra indication for tocolysis
- Signs of fetal distress defined by:
- Decreased movement felt by the mother OR
- Meconium stained amniotic fluid OR
- Non-reassuring patterns seen on cardiotocography
- Signs of intra uterine infection defined by:
- Maternal rectal temperature > 37.8 degrees Celsius AND
- Clinical signs of infection:
- Fetal tachycardia > 160 beats/min
- Maternal tachycardia > 100 beats/min
- Leukocytosis > 15 x109/L
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-okt-2017
- planned closingdate2-okt-2020
- Target number of participants1514
- InterventionsAtosiban
- Primary outcomeThe primary outcome of the study will be a composite adverse perinatal outcome, consisting of bronchopulmonary dysplasia at 36 weeks postmenstrual age (PMA), periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis ≥ stage 2, retinopathy of prematurity > grade 2 or need for laser therapy, culture proven sepsis and perinatal death.
- Secondary outcomeBirth within 48 hours, time to delivery, gestational age at delivery, birth weight, number of days on invasive mechanical ventilation, length of admission in NICU, asphyxia, meningitis, pneumothorax and mortality until 3 months corrected age, maternal infection, maternal side effects and costs.
- TimepointsUp until 3 months corrected age.
- Trial web sitehttp://www.studies-obsgyn.nl/apostel8/page.asp?page_id=1820
- statusplanned
- CONTACT FOR PUBLIC QUERIES Trial bureau of the NVOG Consortium
- CONTACT for SCIENTIFIC QUERIES Trial bureau of the NVOG Consortium
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryThe Netherlands
Belgium
United Kingdom
Ireland
- Main changes (audit trail)
- RECORD24-aug-2017 - 27-aug-2017


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