Comparing 3-hourly with 6-hourly dinoprostone vaginal tablet for labour induction in nulliparous women with an unfavourable cervix at term
Completed
- Conditions
- Pregnancy and Childbirthabour induction in nullliparous women with an unfavourable cervix at term
- Registration Number
- ISRCTN94131405
- Lead Sponsor
- niversity of Malaya (Malaysia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 238
Inclusion Criteria
1. Scheduled for induction of labour
2. Nulliparous (no previous delivery > 20 weeks)
3. Term gestation (= 37 weeks)
4. Bishop score on recruitment = 6
5. Intact membranes
6. Singleton pregnancy
7. Cephalic presentation
8. Reassuring cardiotocogram
Exclusion Criteria
1. Previous uterine incision or injury (e.g. myomectomy, perforation)
2. Known severe fetal anomaly
3. No significant contractions (< 1 in 10 minutes)
4. Allergy to dinoprostone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Vaginal delivery in 24 hours<br>2. Maternal satisfaction with the birth process using a 10 point numerical rating scale
- Secondary Outcome Measures
Name Time Method 1. Mode of delivery (and indications for operative delivery)<br>2. Neonatal outcome (admission, umbilical cord blood pH, Apgar score)<br>3. Analgesia use in during induction and labour<br>4. Cardiotocogram abnormalities in first 12 hours of labour induction (including tachysystole, hypertonus, hyperstimulation)<br>5. Meconium stained liquor<br>6. Blood loss during labour and delivery<br>7. Maternal fever (any maternal temperature = 380 C during labour or before discharge)<br>8. Maternal pain score at 6 hours of labour induction (if undelivered)<br>9. Induction to delivery interval<br>10. Induction to hospital discharge interval