Transcervical Foley Catheter with or without Single Dose Oral Mifepristone in Women with Previous cesarean section on success of Vaginal Delivery

Comparison of Efficacy of Transcervical Foley Catheter with or without Single Dose Oral Mifepris-tone on Vaginal Delivery Among Women Undergoing the Trial of Labour After Caesarean Section at Term A Randomised, Double-blinded, Placebo-Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092685

Enrollment

180

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

None listed

Interventions

Intervention1: Transcervical Foley Catheter 22 Fr for 24 hours with a Single dose of oral Mifepristone 200mg for Induction of labour in Women undergoing TOLAC: Tab. Mifepristone 200 mg single dose ora

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than or equal to 18 years 2. Period of gestation: 370/7 42 weeks 3. Singleton live fetus in cephalic presentation with intact membranes 4. Reactive Non-Stress Test (NST) 5. Bishop score less than or equal to 4 6. Eligible for trial of labour after caesarean section (TOLAC)

Exclusion criteria

Exclusion criteria: 1. Requiring imminent delivery 2. With known contraindications/hypersensitivity to Mifepristone 3. Major fetal anomalies 4. Absolute contraindication for TOLAC

Design outcomes

Primary

Measure	Time frame
Vaginal birth after caesarean rate (VBAC)Timepoint: At 24 hours At 48 hours	—

Secondary

Measure	Time frame
Change in Bishop scoreTimepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier;Need for induction/augmentation with oxytocin (dose/duration)Timepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier till delivery of the baby;Duration of foley-in-situTimepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier;Induction to delivery interval (IDI)Timepoint: Induction of labour with intervention to delivery of the baby;Maternal & Perinatal outcomeTimepoint: at 24 hours of intervention at delivery of the baby at discharge from the hospital	—

Measure

Time frame

Change in Bishop scoreTimepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier;Need for induction/augmentation with oxytocin (dose/duration)Timepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier till delivery of the baby;Duration of foley-in-situTimepoint: at 24 hours of intervention or at expulsion of foley catheter or rupture of membranes, whichever is earlier;Induction to delivery interval (IDI)Timepoint: Induction of labour with intervention to delivery of the baby;Maternal & Perinatal outcomeTimepoint: at 24 hours of intervention at delivery of the baby at discharge from the hospital

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Countries

India

Contacts

Public ContactDrT Parvathi

Jawaharal Institute of Postgraduate Medical Education and Research (JIPMER)

Jd1232@jipmer.ac.in9566537193

Outcome results