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

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094110

Enrollment

114

Registered

2025-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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 followed by oxytocin for induction of labour in previous caesarean section patient with rupture of membranes with unfavourable cervix: Under sterile aseptic

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the rate of vaginal delivery between those induced with transcervical Foley catheter followed by oxytocin with that of oxytocin induction aloneTimepoint: At 24 hours At 48 hours	—

Secondary

Measure	Time frame
Maternal outcome in terms of chorioamnionitis and uterine scar rupture.Timepoint: 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.Timepoint: At 24 hours of intervention At delivery of baby At discharge from the hospital	—

Countries

India

Contacts

Public ContactDr Latha Chaturvedula

Jawaharlal Institute of Postgraduate Medical Education and Research

jipoghod@gmail.com9486008274

Outcome results