To compare Oral Mifepristone with Foley catheter for softening of cervix in women planned for delivery at or after 39 weeks of pregnancy
Phase 2
- Registration Number
- CTRI/2021/07/034943
- Lead Sponsor
- JIPMER INTRAMURA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age � 18 years
2. Period of gestation: 39 to 42 weeks
3. Singleton live fetus with cephalic presentation with reactive Non-stress Test
4. Bishopââ?¬•s score ââ?°Â¤6
5. Intact membranes
6. Planned for induction of labour
7. Unscarred uterus
Exclusion Criteria
1.Absolute contraindications for vaginal delivery
2.Patient requiring imminent delivery
3. Evidence of chorioamnionitis
4.Patients with known contraindications to Mifepristone
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine and compare the change in Bishop score with oral Mifepristone versus trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripeningTimepoint: Bishop score will be reassessed at 24 hours and 48 hours after administration of Tablet Mifepristone
- Secondary Outcome Measures
Name Time Method To determine and compare the efficacy and safety of oral Mifepristone with trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening <br/ ><br>Timepoint: From administration of Mifepristone and Transcervical Foley catheter insertion to delivery of the baby