Randomised controlled trial of comparison of prostaglandin gel insertion versus Foleys catheter insertion into birth canal as a means of artificially starting the process of labour after 37 weeks of pregnancy.
Phase 3
- Conditions
- Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2021/04/032581
- Lead Sponsor
- oufila Abdulla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients requiring induction of labour with
1.Singleton pregnancy
2.37weeks-42 weeks of gestation
3.Clinically adequate pelvis
4.Bishopâ??s score <6
5.Intact fetal membranes
6.Fetus in cephalic presentation
Exclusion Criteria
1.Multifetal pregnancy
2.Malpresentation
3.Antepartum hemorrhage
4.Scarred uterus
5.Estimated fetal weight >4 kg
6.Chorioamnionitis.
7.Major congenital anomalies in fetus
8.Any indication for immediate caesarean section
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mode of delivery <br/ ><br>Change in Bishopâ??s score <br/ ><br>Induction-delivery intervalTimepoint: At delivery <br/ ><br>In labour- at pelvic examination for reassessment of cervical status <br/ ><br>At delivery
- Secondary Outcome Measures
Name Time Method Indication for induction <br/ ><br>Need for augmentation <br/ ><br>Low APGAR score at birth <br/ ><br>NICU (Neonatal intensive care unit) admission <br/ ><br>NICU length of stayTimepoint: Prior to induction <br/ ><br>At reassessment of cervical status <br/ ><br>Immediately after delivery <br/ ><br>3 days after delivery