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

INTERVENTION: Trade Name: tractocile Pharmaceutical Form: Intravenous infusion Trade Name: Partusisten Pharmaceutical Form: Intravenous infusion CONDITION: 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 Classification code 10006356 Term: Breech presentation PRIMARY OUTCOME: 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. 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 Secondary Objective: mode of delivery, side effects, adverse events 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