Health Condition 1: O09- Supervision of high risk pregnancy
Conditions
Interventions
Intervention1: Oral Mifepristone: Initial PV examination to record Bishop score (less than 6) followed by administration of 200 mg oral mifepristone tablet. Reassessment of bishop score after 24 hours
Sponsors
Postgraduate Institute of Medical Education and Research, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 45 Singleton pregnancy Cephalic pregnancy Term 37 to 40 weeks Bishop score less than 6 No contraindications to vaginal delivery or IOL Reactive Non stress test Willing to participate in study Signed informed consent
Exclusion criteria
Exclusion criteria: Previously scarred uterus seen in LSCS, Classical cesarean, Hysterectomy, Myomectomy Premature rupture of membranes, Chorioamniitis Cephalopelvic disproportion Hypersensitivity to study drugs Non reassuring fetal status, severe oligohydramnios, APH Multipla pregnancy Grand multipara Medical disorders like uncontrolled diabetes, uncontrolled hypertension, impaired genetic and renal function, cardiac steroids, glaucoma Patient on steroids patient with known, Gross congenitaj malformation refusal of conssrnt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Mifepristone for cervical ripening and induction of labour in terms of Mean change of Bishop score after 24 hours and induction to delivery interval (in hours)Timepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| A. To study the need of addtional agents of cervical ripening & IOL in group receiving Mifepristone B. To compare outcomes of cervical ripening & IOL between both groups in terms of 1. Need for oxytocin augmentation 2. Rate of failed induction (Number, mode of delivery, outcomes of pregnancy) 3. Rate of cesarean section & indication 4. Intrapartum maternal & fetal events (fetal distress, non progress of labour, tachysystole, uterine rupture, instrumental delivery, PPH) 5. Fetal outcomes (APGAR, NICU admissions) 6. Failed inductions (Number, mode of delivery, outcomes of pregnancy) Timepoint: A. Additional agents required after 24 hours of Mifepristone till delivery B. 1. Need for oxytocin 24 hours after Mifepristone till delivery in intervention group & from after last dose of gel till delivery in comparison group 2. Failure of IOL after 24 hours of mifepristone & 3 doses of gel in mifepristone group & Failure of induction after 3 doses of gel in dinoprostone group 3. After delivery 4. During delivery 5. from delivery to 24 hours after delivery | — |
Countries
India
Contacts
Public ContactDr Anshika Jain
Postgraduate institute of medical education and research, Chandigarh
Outcome results
None listed