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Use 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 gestation

Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labour on an out-patient basis in low risk pregnant women with past dates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026333
Enrollment
188
Registered
2020-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Oral Mifepristone 200mg: Patients who fit in the inclusion and exclusion criteria will be consented to take part in the study. Non stress test will be performed prior to Induction. Pat

Sponsors

Internal Fluid Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women at term ( >40 weeks and above) with singleton pregnancy in cephalic presentation

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
1. Rate of successful vaginal delivery 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 2. Improvement in Bishopâ??s score after 48 hours of induction or at the time of onset of labour

Secondary

MeasureTime frame
a. Maternal 1.Need / Number of doses of Misoprostol required on admission 2.Need and dose of oxytocin for augmentation of labour 3.ARM to delivery interval 4.Maternal Morbidity â?? ICU admissions, Blood transfusions (if any) b.FOETAL 1.CS for NRFS / Failed induction 2.APGAR SCORE at 5 and 10 minutes 3.Neonatal intensive care unit (NICU) admissionsTimepoint: 72 hours

Countries

India

Contacts

Public ContactElza Rebecca Kharsyntiew

Christian Medical College Vellore

anuja@cmcvellore.ac.in9486543840

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026