External Cephalic Version with uterine-relaxation: atosiban versus fenoterol; a multi centre trial.
- Conditions
- stuitligging, uitwendige versie, uterus relaxatie, atosiban, oxytocine antagonist, fenoterol, betamimetica.UK: breech presentation, external cephalic version, uterine relaxation, atosiban, oxytocine antagonist, fenoterol, betamimetics.
- Registration Number
- NL-OMON20784
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 806
Inclusion Criteria
1. Pregnant women (from 18 years of age) with a live singleton fetus in breech presentation;
2. 32 weeks of gestation and onwards.
Exclusion Criteria
1. Contraindications to labour or vaginal birth;
2. Any contraindication to ECV;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Succesfull version; number of cephalic presentations half an hour after the procedure;<br /><br>2. Fetal presentation at delivery.<br>
- Secondary Outcome Measures
Name Time Method 1. Mode of delivery; vaginal delivery (spontaneous or instrumental), CS (prelabor or during labor);<br /><br>2. Complications of ECV; persistent non-reassuring fetal CTG after ECV, umbilical cord prolapse, (P)PROM, placental abruption, emergency delivery, fetal death;<br /><br>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.<br>