A trial to study the usefulness of an already marketed tablet Mifepristone 200 mg as compared to other methods in preparing the reproductive tract for delivery in term pregnancy.
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated delivery
- Registration Number
- CTRI/2019/06/019821
- Lead Sponsor
- Paily V P
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A. Primigravida singleton pregnancy at or more than 39 weeks gestation with cephalic presentation and intact membranes and no complications other than Gestational Diabetes Mellitus.
B. Modified Bishop Score less than 6.
C. Patient should not have any contraindications for vaginal delivery
A. Multi-parity
B. Multiple pregnancy
C. Premature rupture of Membranes
D. Previous Cesarean Section
E. Scarred uterus
F. Uterine Anomalies
G. Malpresentations
H. Bad Obstetric History
I. Cephalo-pelvic Disproportion, Short Primi (height <145cm)
J. Indicated Induction for Gestational Hypertension, overt Diabetes and Gestational
Diabetes Mellitus on Insulin.
K. Fetal anamolies
L. Fetal growth restriction
M. Chronic Adrenal Failure
N Contraindications for oral Mifepristone
O. History of Allergic Reactions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Interval between Induction of Labour and deliveryTimepoint: 1. Time of Induction of labour by medical or mechanical methods as indicated. <br/ ><br>2. Time of delivery of baby
- Secondary Outcome Measures
Name Time Method to determine the effect of oral mifeprestione 200 m.g. on <br/ ><br>A. Mode of Delivery <br/ ><br>B. Requirement of Epidural <br/ ><br> analgesia <br/ ><br>c.Incidence of Maternal Complications <br/ ><br>d. Incidence of Neonatal complications like hypoglycemia and acidosis <br/ ><br>Timepoint: after administration of Oral Mifepristone 200 m.g.