To compare Foleys plus PGE2 gel with Foleys plus PGE1 tablet for cervical ripening and induction of labour
Phase 2
- Conditions
- Health Condition 1: null- term patients
- Registration Number
- CTRI/2017/12/010738
- Lead Sponsor
- no sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Singleton pregnancy with cephalic presentation
2. Gestational age >=34weeks
3. Bishopâ??s score <=6
4. Intact membranes
5. Reactive non-stress test
Exclusion Criteria
1. Uterine scar
2. Antepartum haemorrhage
3. Intrauterine fetal anomaly or death
4. Cervicovaginal infection
5. Heart disease, seizure disorder , severe anaemia, uncontrolled diabetes
6. Severe fetal growth restriction, severe pre-eclampsia
7. Parity >3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the induction delivery interval (IDI) with two combined methods used for cervical ripening and IOL <br/ ><br>a.Foleyâ??s catheter and intracervical dinoprostone gel (0.5mg) <br/ ><br>b.Foleyâ??s catheter and vaginal. misoprostol (25µg <br/ ><br>Timepoint: 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method To determine the following with the above two methods <br/ ><br>1. Change in Bishopâ??s score after 12 hours <br/ ><br>2. Caesarean section (CS) rate <br/ ><br>3. Uterine contraction abnormalities <br/ ><br>4. Infectious morbidity in the mother and the neonate <br/ ><br>5. Neonatal outcome <br/ ><br>Timepoint: 1 year