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A study to see if a tablet(Mifepristone)helps prepare the birth canal for easier labour in pregnant women reaching their full term.

Assessing the efficacy of mifepristone in improving the preinduction cervical ripening at term gestation in a tertiary health centre : a double blind , randomized , placebo-control superiority trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100980
Enrollment
140
Registered
2026-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: O610- Failed medical induction of labor

Interventions

Intervention1: Drug-Mifepristone: Dosage- 200mg po Route - oral Frequency - single dose Timing - administered at term gestation for preinduction cervical ripening Control Intervention1: Placebo: Simil

Sponsors

RNT Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women aged 18 to 35 years undergoing labour with singleton pregnancy Period of gestation between 37 to 42 weeks in cephalic presentation and labor induction is indicated in next 24 to 48 hours. 2.Reactive Fetal heart rate & BISHOP score less than 6.

Exclusion criteria

Exclusion criteria: 1.Two or more previous Caesearn Sections or classical Caesearn section. 2.Gynaecological interventions such as myomectomy, Manchester repair or perineorrhaphy 3.Suspected abruption of placenta or radiological evidence of low lying placenta 4.Any obstetric contraindication to labour induction and obstetrics emergencies.

Design outcomes

Primary

MeasureTime frame
To compare the difference in fetal APGAR score and birth weight in intervention and control group.Timepoint: Baseline,24 hours and 48 hours post delivery in intervention and control group.

Secondary

MeasureTime frame
To compare the incidence rate of cesarean section in intervention & control group. Timepoint: To be compare for 1 year or till the total sample size reach.;To estimate the difference in time to normal vaginal delivery following interventionTimepoint: Time taken from intervention till the baby delivery.

Countries

India

Contacts

Public ContactDr Nirmal Kanwar

RNT Medical College

gandhisudha70@yahoo.com7014761838

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026