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External Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.


- candidate number6017
- NTR NumberNTR1877
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2009
- Secondary IDs26246 METC AMC
- Public TitleExternal Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.
- Scientific TitleExternal Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.
- ACRONYMECV with uterine relaxation
- hypothesisExternal cepahlic version (ECV) of the fetus in breech position is a safe and relative simple obstetric intervention to reduce the incidence of caeserean section for breech position at term. Uterine relaxants can enhance the success rate of ECV with 40%. Betamimetica (fenoterol) is proven effective as uterine relaxant in ECV, but has several side effects due to which it is not used on daily basis. This trial will compare the effectiveness of atosiban with fenoterol during ECV in women with a singleton fetus in breech presentation at term.
- Healt Condition(s) or Problem(s) studiedOxytocine antagonist, Breech presentation, external cephalic version
- Inclusion criteria1. Pregnant women (from 18 years of age) with a live singleton fetus in breech presentation;
2. 32 weeks of gestation and onwards.
- Exclusion criteria1. Contraindications to labour or vaginal birth;
2. Any contraindication to ECV;
3. Contra-indications for fenoterol or atosiban.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-jul-2013
- Target number of participants806
- InterventionsComparison of a bolus atosiban 6,75 mg iv compared to a bolus 40 micrograms iv 15 minutes before ECV.
- Primary outcome1. Succesfull version; number of cephalic presentations half an hour after the procedure;
2. Fetal presentation at delivery.
- Secondary outcome1. Mode of delivery; vaginal delivery (spontaneous or instrumental), CS (prelabor or during labor);
2. Complications of ECV; persistent non-reassuring fetal CTG after ECV, umbilical cord prolapse, (P)PROM, placental abruption, emergency delivery, fetal death;
3. Adverse events due to atosiban or fenoterol; chest pain, nausea, vomitting, headaches, flushing, dizziness, hypotension (associated with fainting or CTG abnormalities), tachycardia resulting in palpitations, local reaction of the skin on injection of the medication, anaphylactic shock, cessation of treatment due to side effects.
- TimepointsN/A
- Trial web sitewww.studies-obsgyn.nl/ecv/page.asp?page_id=720
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, MSc F. Vlemmix
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Obstetrics and Gynecology
- PublicationsN/A
- Brief summaryExternal cephalic version (ECV) is proven effective to reduce the number of caesarean sections in breech presentation at term. Untill now, betamimetics are the only effective uterine relaxants; they increase the succes rate of ECV by 40% and consequently lower the number of caeserean sections. Nevertheless, this medication has side effects which often leads to palpitations. Therefore, implementation of this treatment is limited. In this study, we compare fenoterol with atosiban to find out if atosiban is comparable to fenoterol in women with a breech presentation at term.
- Main changes (audit trail)
- RECORD25-jun-2009 - 6-okt-2009


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