CTRI

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CTRI Number

CTRI/2025/09/094110 [Registered on: 02/09/2025] Trial Registered Prospectively

Last Modified On:

01/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Medical Device

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study comparing two ways to start labour in women over 36 weeks pregnant with a previous C-Section and broken waters: Using a Balloon catheter(foley ) and medicine(oxytocin) vs medicine(oxytocin) alone

Scientific Title of Study

A randomized controlled trial comparing outcomes of labour induction with transcervical Foley catheter and oxytocin with oxytocin alone in women with previous one caesarean section and pre labour rupture of membranes with an unfavourable cervix at 36 weeks and beyond

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Dharshini K K
Designation	Junior Resident Obstetrics and Gynaecology
Affiliation	Jawaharlal Institute of Postgraduate Medical Education and Research
Address	OG office, 2nd floor, Department of Obstetrics and Gynaecology, WCH block, Jawharlal Institute of Postgraduate Medical Education and Research,Gorimedu, Pondicherry Pondicherry PONDICHERRY 605006 India
Phone	8667371408
Fax
Email	dharshinikolanthasamy09@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Latha Chaturvedula
Designation	Professor Obstetrics and Gynaecology
Affiliation	Jawaharlal Institute of Postgraduate Medical Education and Research
Address	OG Office,2nd floor, Department of Obstetrics and Gynaecology,WCH block, Jawharlal Institute of Postgraduate Medical Education and Research,Gorimedu,Dhanvantri nagar, Puducherry Pondicherry PONDICHERRY 605006 India
Phone	9486008274
Fax
Email	jipoghod@gmail.com

Details of Contact Person
Public Query

Name	Dr Latha Chaturvedula
Designation	Professor Obstetrics and Gynaecology
Affiliation	Jawaharlal Institute of Postgraduate Medical Education and Research
Address	OG Office,2nd floor, Department of Obstetrics and Gynaecology,WCH block, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu,Dhanvantri nagar, Puducherry Pondicherry PONDICHERRY 605006 India
Phone	9486008274
Fax
Email	jipoghod@gmail.com

Source of Monetary or Material Support

Jawaharlal Institute of Postgraduate Medical Education and Research

Primary Sponsor

Name	JIPMER
Address	JIPMER Campus,Gorimedu, Dhanvantri Nagar, Pondicherry 605006
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Latha Chaturvedula	Jawaharlal Institute of Postgraduate Medical Education and Research	OG office, 2nd floor , Department of Obstetrics and Gynaecology,Women and children hospital, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Pondicherry Pondicherry PONDICHERRY	9486008274 jipoghod@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE - INTERVENTIONAL STUDIES	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Pregnant women with previous LSCS and premature rupture of membranes planned for induction of labour

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Oxytocin for induction of labour in previous caesarean section patient with rupture of membranes with unfavourable cervix	Oxytocin will be started after 6 hours of PROM for women with low Bishop score, at the rate of 2 mU/min. Oxytocin will be increased at the rate of 2 mU/min for every 30 mins till effective contractions (3 contractions in 10 minutes lasting at least for 45 seconds) are achieved up to a maximum of 20 mU/min for 12 hours or till delivery whichever is earlier
Intervention	Transcervical foley catheter followed by oxytocin for induction of labour in previous caesarean section patient with rupture of membranes with unfavourable cervix	Under sterile aseptic precautions, a 22 Fr transcervical Foley catheter will be inserted into the cervix up to the internal os after at least 6 hours of membrane rupture and inflated with 70 ml normal saline. The catheter will be strapped to the thigh and kept in situ for a maximum of 12 hours or until spontaneous expulsion, whichever occurs first. If active labour does not begin, oxytocin will be started at 2 mU/min, increasing by 2 mU/min every 30 minutes until effective contractions (3 in 10 minutes, each lasting at least 45 seconds) are achieved, up to a maximum of 20 mU/min for 12 hours or until delivery

Inclusion Criteria

Age From	20.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	1.Pregnant women with previous one caesarean section and premature rupture of membranes,eligible for TOLAC at 36 weeks and above. 2.Age: 20-35 years 3.Singleton pregnancy with cephalic presentation 4.Rupture of membranes less than 12 hours duration 5.Bishop score of less than or equal to 4 at admission. 6.Clear liquor at recruitment

ExclusionCriteria

Details

1.Clinical evidence of chorioamnionitis
2.Severe preeclampsia
3.Heart disease (RHD/ Congenital – uncorrected)
4.People living with HIV/AIDS
5.Severe anemia
6.Diabetes mellitus on Insulin therapy

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To compare the rate of vaginal delivery between those induced with transcervical Foley catheter followed by oxytocin with that of oxytocin induction alone	At 24 hours At 48 hours

Secondary Outcome

Outcome	TimePoints
Maternal outcome in terms of chorioamnionitis and uterine scar rupture.	At 24 hours of intervention At delivery of baby At discharge from the hospital
Neonatal outcome in terms of APGAR scores at 1 and 5 minutes, NICU admissions, and neonatal sepsis.	At 24 hours of intervention At delivery of baby At discharge from the hospital

Target Sample Size

Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

01/10/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="8"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This prospective randomized controlled trial compares transcervical Foley catheter followed by oxytocin vs oxytocin alone for labor induction in women with one previous cesarean, premature rupture of membranes, and an unfavorable cervix at 36 weeks and beyond. It assesses efficacy, safety, and maternal and neonatal outcomes.Mechanical method like transcervical Foley catheter has gained popularity as safer alternatives to prostaglandins for cervical ripening in women with previous cesarean delivery, as they avoid the risks of uterine rupture associated with pharmacological ripening agents.Induction with transcervical foleys catheter followed by oxytocin would be more efficacious in reducing the use of uterotonic agents and induction delivery interval thereby increasing VBAC rate and decreasing the risk of scar dehiscence and scar rupture.