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Comparison between combination regimes consisting of oral Mifepristone and intracervical Foley’s catheter with oral Mifepristone or intracervical Foleys catheter used singly for induction of labor in women with previous cesarean birth and dead fetus in utero at late third trimester

RANDOMIZED CONTROLLED TRIAL COMPARING EFFICACY OF A COMBINATION REGIME CONTAINING TWO CERVICAL SENSITIZERS (MIFEPRISTONE + FOLEY’S CATHETER) VERSUS SINGLE AGENT MIFEPRISTONE OR FOLEY’S CATHETER FOR LABOR INDUCTION IN WOMEN ATTEMPTING TOLAC AT LATE THIRD TRIMESTER WITH A DEAD FETUS IN UTERO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/012173
Enrollment
252
Registered
2018-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: null- Induction of labor in patients presenting with IUFD after 28 weeks of gestation Health Condition 2: O758- Other specified complications of labor and delivery Health Condition 3: O098- Supervision of other high risk pregnancies

Interventions

Intervention1: Mifepristone followed by Foley’s catheter: Intervention group will receive mifepristone tablet 400mg on day1. She will be reassessed after 24 hours and if bishop score is still 6 a seco

Sponsors

Department of Obstetrics and Gynaecology Chittaranjan Seva Sadan and Shishu Sadan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women of age 20 years and above, with a history of previous cesarean birth, singleton pregnancy, IUFD diagnosed at a gestational age of 34 weeks or above and with bishop score (BS) = 6 were eligible for recruitment.

Exclusion criteria

Exclusion criteria: Women with known allergy/contraindication to the use of mifepristone, previous two or more caesarean births (or myomectomy), evidence of coagulopathy, serious medical complications, low-lying placenta, clinical suspicion of chorioamnionitis, any systemic infection at the time of examination and multi-parity (parity > four) were excluded.

Design outcomes

Primary

MeasureTime frame
Number of women undergoing vaginal birth within 48 hours (VB48) of starting the induction procedureTimepoint: time of delivery of fetus following initiation of induction—

Secondary

MeasureTime frame
total number of women undergoing vaginal birth in the different groups, IBI, total dose of oxytocin infusion, duration of oxytocin infusion and post procedure maternal complications.Timepoint: birth related parameters- time of delivery of fetus post procedure maternal complications- Upto 6 months after birth—

Countries

India

Contacts

Public ContactDr Subhankar Dasgupta

Chittaranjan Seva Sadan and Sishu Sadan, College of Obstetrics Gynaecology and Child Health

subhankar74@gmail.com91-9874836437

Outcome results

None listed

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