se of Oral Mifepristone on an out-patient basis to aid onset of normal labour pain in low risk pregnant women more than 40 weeks of gestatio
Phase 3
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated delivery
- Registration Number
- CTRI/2020/07/026333
- Lead Sponsor
- Internal Fluid Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pregnant women at term ( >40 weeks and above) with singleton pregnancy in cephalic presentation
Exclusion Criteria
1.Previous LSCS
2.Hypertension, pre-eclampsia
3.IUGR, oligohydraminos
4.Diabetes on Insulin
5.Low lying placenta
6.Chorioamnionitis or rupture of membranes
7.Bishop score more than 6 at the time of enrolment
8.Non- reactive NST
9.Intra-uterine foetal death
10.Any contraindication for vaginal delivery (e.g., cephalo-pelvic disproportion)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rate of successful vaginal delivery <br/ ><br>2. Improvement in Bishopâ??s score after 48 hours of induction or at the time of onset of labourTimepoint: 1. Rate of successful vaginal delivery <br/ ><br>2. Improvement in Bishopâ??s score after 48 hours of induction or at the time of onset of labour
- Secondary Outcome Measures
Name Time Method a. Maternal <br/ ><br>1.Need / Number of doses of Misoprostol required on admission <br/ ><br>2.Need and dose of oxytocin for augmentation of labour <br/ ><br>3.ARM to delivery interval <br/ ><br>4.Maternal Morbidity â?? ICU admissions, Blood transfusions (if any) <br/ ><br>b.FOETAL <br/ ><br>1.CS for NRFS / Failed induction <br/ ><br>2.APGAR SCORE at 5 and 10 minutes <br/ ><br>3.Neonatal intensive care unit (NICU) admissionsTimepoint: 72 hours