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External cephalic version trial.


- candidate number1230
- NTR NumberNTR140
- ISRCTNISRCTN28715121
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleExternal cephalic version trial.
- Scientific TitleManagement of breech presentation: external cephalic version with tocolysis: a multicentre randomised controlled trial.
- ACRONYMN/A
- hypothesisFor women with a singleton at term fetus in breech presentation, what is the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication?
- Healt Condition(s) or Problem(s) studiedBreech presentation
- Inclusion criteriaPregnant women (from 18 years of age) with a live singleton at term fetus in breech presentation.
- Exclusion criteriaContraindications to labour or vaginal birth, any contraindication to ECV, contra-indications for nifedipine.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2004
- planned closingdate1-mei-2006
- Target number of participants300
- InterventionsGroup 1:
external cephalic version with tocolysis (adalat 10 mg orally 30 and 15 minutes before procedure);
Group 2:
external cephalic version without tocolysis.
- Primary outcomeSuccesfull version.
- Secondary outcome1. Cephalic presentation at birth;
2. Caesarean section rate;
3. Fetal complications;
4. Maternal complications.
- TimepointsN/A
- Trial web sitehttp://www.stuitonderzoek.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M. Kok
- CONTACT for SCIENTIFIC QUERIESDr. M. Kok
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsObstet Gynecol. 2008 Aug;112(2 Pt 1):271-6.
- Brief summaryExternal cephalic version (ECV) without tocolysis after 36 weeks of gestation can reduce the breech presentation by 41%. ECV with tocolysis is more successful and has a success rate of 57%.
Currently used tocolytics have maternal cardiovascular side-effects in terms of flushing and palpitations and therefore seldom used in clinical practice. A new tocolytic nifedipine, a calcium antagonist exists wich has significant less side effects(5).
Therefore, the goal of this trial is to asses for women with a singleton at term fetus in breech presentation the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication?
- Main changes (audit trail)
- RECORD17-aug-2005 - 18-nov-2008


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