Randomised trial comparing intrauterine balloon catheter with 30ml fluid with intrauterine balloon catheter with 80ml of fluid to start labor in women with one previous caesarean section.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Pregnant woman planned for induction
- Registration Number
- CTRI/2014/02/004412
- Lead Sponsor
- Christian Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
Previous one LSCS, singleton pregnancy in cephalic presentation and gestational age 34 plus 6 weeks or more requiring induction of labour
Exclusion Criteria
All contraindication for trial of scar
Women not willing for vaginal birth after caesarean, previous endometritis, previous pregnancy interval less than 18 months, previous extension of incision or myomectomy scar and EFW 4 kgs or more
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal deliveryTimepoint: 24 hours
- Secondary Outcome Measures
Name Time Method Effectiveness Change in Bishop score, need for oxytocin augumentation <br/ ><br>Complications Uterine hyperstimulation with FHR change, chorioamnionitis,meconium stained liquor, apgar score less than 7 at 5 min, need for NICU admission, postpartum fever or endometritis, serious maternal outcomes, neonatal sepsis <br/ ><br>Satisfaction Caregiver and mother not satisfiedTimepoint: As above