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.

To Study The Effect of Oral Mifepristone as an Adjunct to Other Methods of Pre-induction Cervical Ripening in Term Pregnancy â?? A Randomized Controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019821

Enrollment

100

Registered

2019-06-24

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 200 m.g.once. Total duration of therapy is one day.: For pre-induction cervical ripening in term pregnancy Control Intervention1: placebo- Oral calcium 500 m.g. once.

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
Interval between Induction of Labour and deliveryTimepoint: 1. Time of Induction of labour by medical or mechanical methods as indicated. 2. Time of delivery of baby	—

Secondary

Measure	Time frame
to determine the effect of oral mifeprestione 200 m.g. on A. Mode of Delivery B. Requirement of Epidural analgesia c.Incidence of Maternal Complications d. Incidence of Neonatal complications like hypoglycemia and acidosis Timepoint: after administration of Oral Mifepristone 200 m.g.	—

Countries

India

Contacts

Public Contactajitha kumari sudhamma

Rajagiri hospital

vp.paily@rajagirihospital.com04842905000

Outcome results

None listed

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