External Cephalic Version with uterine relaxation: atosiban versus fenoterol, a multi-centre trial - ECV: atosiban vs fenoterol
- Conditions
- ECV of the fetus in breech position is a safe and relatively simple obstetrical intervention that reduces the incidence of caesarean section for breech position at term. Tocolysis can enhance the success rate of ECV with 40%. This trial will compare the effectiveness of atosiban with fenoterol during ECV in women with a singleton fetus in breech presentation at term.MedDRA version: 9.1Level: LLTClassification code 10006356Term: Breech presentation
- Registration Number
- EUCTR2008-007344-34-NL
- Lead Sponsor
- Academic Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1.Live singleton fetus
2.Breech presentation
3.Gestational age of 32 weeks and onwards
4.Maternal age of 18 years or more
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Maternal exclusion criteria;
-Any contra-indications to labour or vaginal birth (eg placenta praevia)
-Any contra-indication to ECV:
- A scarred uterus other than transverse in the lower segment
- Known uterine anomalies
- Placental abruption in the obstetric history
- Preeclampsia or eclampsia
- Third trimester blood loss
- Ruptured membranes
-Any contra-indication to atosiban or fenoterol:
- Cardiovascular disease
- Hyperthyreoidism
- Elevated liver enzymes or renal dysfunction
- Infection of the amniotic cavity
- Simultaneous use of prostaglandin inhibitors, beta-blockers (labetalol
(trandate)), xanthine derivatives (theofylline), tricyclic antidepressants,
calcium, vitamin D, mineralocorticoids.
- Use of prostaglandin inhibitors, beta-blockers (labetalol) tricyclic
antidepressants.
Fetal exclusion criteria;
-Suspected severe intrauterine growth restriction ( assessed by ultrasonography) or severe oligohydramnios (deepest pool <
2 cm)
-Fetal anomalies or an extended fetal head (very rare)
-Non reassuring signs of fetal well-being; non-reassuring fetal heart rate
monitoring
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effectiveness of atosiban compared to fenoterol in External Cephalic Version (ECV) of breech presentation at term; the effect on precentage cephalic presentation half an our after ECV and at birth.;Secondary Objective: mode of delivery, side effects, adverse events;Primary end point(s): - Succesfull version; number of cephalic presentations half an hour after the procedure<br>- Fetal presentation at delivery<br>- Mode of delivery<br>- Neonatal complications<br>- Maternal complications
- Secondary Outcome Measures
Name Time Method