External Cephalic Version (ECV) Tocolysis Trial: Oral nifedipine vs subcutaneous terbutaline

Completed

Conditions: Breech presentation at term gestation
Pregnancy and Childbirth
Maternal care for known or suspected malpresentation of fetus

Registration Number: ISRCTN14802064

Lead Sponsor: niversity of Malaya Medical Centre (Malaysia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 90

Inclusion Criteria

1. Breech presentation or transverse lie
2. Viable, singleton pregnancy
3. Gestation age 36 to 41 weeks
4. Intact membranes
5. Not in established labour

Exclusion Criteria

1. Known gross foetal anomaly
2. Severe hypertension
3. Intrauterine growth restriction
4. Oligohydramnios
5. Antepartum haemorrhage within last 3 months
6. Uterine scar from any source
7. Known allergy to nifedipine or terbutaline
8. Other potential obstetric indication for Caesarean delivery
8.1. Placenta praevia
8.2. Suspected macrosomia >4 kg
8.3. Uterine anomaly
8.4. Obstructive pelvic tumour

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Successful version to cephalic presentation <br>2. Caesarean delivery

Secondary Outcome Measures

Name	Time	Method
1. Cephalic presentation at birth<br>2. Post-ECV cardiotocographic anomalies<br>3. Visual analogue scale satisfaction score with ECV procedure<br>4. Onset of labour<br>5. Neonatal outcome<br>6. Survey on patient preference of oral vs injection mode of medication<br>7. Maternal peri-delivery blood loss<br>8. Indication for operative delivery<br>9. Adverse drug events