use of mifepristone for induction of labor in women with previous one low segment cesarean section comparison with mechanical stretching of cervix
- Conditions
- Health Condition 1: null- pregnant patients 40 weeks gestation with single cephalic pregnancy & previous one low segment cesarean section
- Registration Number
- CTRI/2012/06/002733
- Lead Sponsor
- DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 107
•Singleton pregnancy
•Previous one low segment cesarean section, no other uterine scar or previous rupture
•Gestation beyond 40 weeks
•Cephalic presentation
•Inter-conceptional period less than 18 months
•Estimated fetal birth weight > 4kg
•Poor modified bio-physical profile
(Amniotic fluid index < 5 cm or non-reassuring non stress test)
•Poor dating ( not sure of dates, no ultrasonography in first trimester or two serial ultrasounds 4 weeks apart in second trimester)
•Premature rupture of membranes/ chorio-amniotis
•Premature rupture of membranes/ chorio-amniotis
•Evidence of fetal distress at admission
•Intra-uterine fetal death
•Any maternal disease ie hypertension, diabetes, renal disease, liver disease, cardiac disease, epilepsy or any chronic medication
•Any contraindication for vaginal delivery ( cephalo-pelvic disproportion ruled out)
•Type of caesarean section not known ( classical or low segment)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the proportion of women entering labor after use of mifepristone alone as compared to sweeping stretching of cervix or use of trans-cervical folleyâ??s catheter.Timepoint: 48 hours after intervention & subsequently delivery of fetus
- Secondary Outcome Measures
Name Time Method â?¢Proportion of women vaginally delivered in each group <br/ ><br>â?¢Proportion of women with cesarean section in each group <br/ ><br>â?¢Duration of labor in women in each group <br/ ><br>â?¢Need and amount of oxytocin required in each group <br/ ><br>â?¢Proportion of women with scar dehiscence/ rupture in each group <br/ ><br>â?¢Neonatal outcomes <br/ ><br>â?? <br/ ><br>Timepoint: 48 hours