Health Condition 1: O80- Encounter for full-term uncomplicated delivery
Conditions
Interventions
Intervention1: Mefipristone 200 mg given: Mefipristone 200 mg given 48 hours prior to induction agent in study arm
Control Intervention1: Placebo: Placebo given 48 hours prior to induction of labour
Sponsors
Indian Navy
Eligibility
Inclusion criteria
Inclusion criteria: Age between 18 and 40 years; singleton live pregnancies; cephalic presentation, unripe uterine cervix at the moment of enrollment (Bishop score less than 6), intact membranes, reactive FHR pattern in live fetus, no contraindication for vaginal delivery and no contraindication for labor induction with mifepristone or prostaglandin . (Bishop score will be calculated as recommended by Royal College of Obstetricians and Gynecologists)
Exclusion criteria
Exclusion criteria: Myoma / uterine anomaly, parity greater than 3, severe hyper- tension/preeclampsia, prior cesarean deliveries, impaired renal, adrenal, or hepatic function, fetal malformations, breech presentation, estimated fetal weight ( >4500 or <2500g), any concerns about the well-being of the fetus, any medical indication for scheduled cesarean delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary aim is to evaluate the change in Bishopââ?¬â?¢s score with oral mifepristone in term pregnancy and to assess number of women going into spontaneous labor within 48 hours.Timepoint: Primary aim is to evaluate the change in Bishopââ?¬â?¢s score with oral mifepristone in term pregnancy and to assess number of women going into spontaneous labor within 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is to assess the enrollment-induction to delivery interval; mode of delivery; and neonatal outcomes (NICU admission more than 24 hours).Timepoint: 48 hours | — |
Countries
India
Contacts
Public ContactVAIDEHI THAKUR
INHS KALYANI
Outcome results
None listed