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: 9.1 Level: LLT Classification code 10006356 Term: Breech presentation MedDRA version: 9.1 Level: LLT Classificat
Conditions
Interventions
Trade Name: tractocile
Pharmaceutical Form: Intravenous infusion
Trade Name: Partusisten
Pharmaceutical Form: Intravenous infusion
Sponsors
Academic Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 (<P5 for gestational age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Fetal presentation at delivery - Mode of delivery - Neonatal complications - Maternal complications | — |
Countries
Netherlands
Outcome results
None listed