Placing the Foley balloon catheter adjacent to the inner portion of the neck of the womb for 12 compared to 24 hours to induce labour in women who had one prior caesarean birth
Not Applicable
- Conditions
- Pregnancy and ChildbirthInduction of labour after one previous caesarean section
- Registration Number
- ISRCTN11513144
- Lead Sponsor
- niversity Malaya Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 132
Inclusion Criteria
1. Scheduled labour induction
2. One previous lower segment caesarean
3. Singleton fetus (one baby)
4. Term: = 37 weeks of pregnancy
5. 18 years and above
6. Cephalic presentation (head first)
7. Reassuring fetal heart rate tracing (baby in good condition)
8. Unripe cervix (Modified Bishop Score = 6)
9. Absence of significant painful contraction (= 2 in 10 minutes)
10. Intact membranes
11. Successful Foley balloon insertion for IOL
Exclusion Criteria
1. Latex Allergy
2. Estimated fetal weight = 2kg or = 4kg before induction and confirmed by ultrasound
3. Known major fetal malformations
4. Contraindications for vaginal delivery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal satisfaction with the birth experience will be assessed using the following measures before hospital discharge:<br>1. 12 vs 24 hours duration of Foley balloon placement using a 0-10 numerical rating scale (NRS)<br>2. Choice vs Randomized using a 0-10 NRS<br>3. 12-hour duration by choice vs 12-hour duration as randomized using a 0-10 NRS<br>4. 24-hour duration by choice vs 24-hour duration as randomized using a 0-10 NRS<br>
- Secondary Outcome Measures
Name Time Method