Oral misoprostol compared to intracervical Foley catheter for induction of labour

Phase 3

• Conditions: Induction of labour

• Registration Number: SLCTR/2016/024
• Lead Sponsor: Department of Obstetrics and Gynecology Faculty of Medicine, University of Ruhuna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete: follow up complete
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. Women with uncomplicated pregnancies
2. 40 weeks + 5 days gestation
3. Modified Bishop score (MBS) of < 6
4. Singleton pregnancy
5. Cephalic presentation
6. Intact membranes

Exclusion Criteria

1. Pregnancy induced hypertension
2. Gestational diabetes mellitus
3. Fetal growth restriction
4. Previous caesarean delivery
5. Scarred uterus
6. Hypersensitivity to misoprostol
7. Contraindication for a vaginal delivery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Number of women establishing labour or<br>becoming favorable for induction of labour (IOL) with Modified Bishop’s Score (MBS) > 6 within 48 hours<br><br>2. Change in MBS after 48 hours of the intervention<br><br>3. Intervention to delivery time in those who established labour following intervention at 40 weeks + 5 days of gestation<br><br>4. The induction delivery interval (IDI),following IOL with antimony and oxytocin 48 hours after the interventions, in those favorable for IOL<br> [After 48 hours of the intervention]<br>

Secondary Outcome Measures

Name	Time	Method
1. Mode of delivery and the reason for operative delivery<br>2. Oxytocin use <br>3. Maternal morbidity<br>• Post partum blood transfusion and number of packed cells <br>• Uterine Hyperstimulation<br>• Uterine rupture <br>• Maternal infection during labour <br>• Use of intravenous antibiotics <br><br>4. Fetal and Neonatal outcome and morbidity: <br>• Suspicious cardiotocogram (CTG)<br>• Pathological CTG<br>• Birth weight<br>• Meconium-stained liquor <br>• APGAR scores < 5 at 1 minute <br>• Admission to the neonatal ward / NICU and its reason <br><br><br><br><br><br><br><br> [At the time of discharge of the mother and the baby from the hospital]<br>