|- candidate number||1230|
|- NTR Number||NTR140|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||24-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||External cephalic version trial.|
|- Scientific Title||Management of breech presentation: external cephalic version with tocolysis: a multicentre randomised controlled trial.
|- hypothesis||For 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) studied||Breech presentation|
|- Inclusion criteria||Pregnant women (from 18 years of age) with a live singleton at term fetus in breech presentation. |
|- Exclusion criteria||Contraindications to labour or vaginal birth, any contraindication to ECV, contra-indications for nifedipine.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2004|
|- planned closingdate||1-mei-2006|
|- Target number of participants||300|
|- Interventions||Group 1:|
external cephalic version with tocolysis (adalat 10 mg orally 30 and 15 minutes before procedure);
external cephalic version without tocolysis.
|- Primary outcome||Succesfull version.|
|- Secondary outcome||1. Cephalic presentation at birth; |
2. Caesarean section rate;
3. Fetal complications;
4. Maternal complications.
|- Trial web site||http://www.stuitonderzoek.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Kok |
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Kok |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Publications||Obstet Gynecol. 2008 Aug;112(2 Pt 1):271-6.|
|- Brief summary||External 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)|
|- RECORD||17-aug-2005 - 18-nov-2008|