Randomised trial comparing intrauterine balloon catheter with 30ml fluid with intrauterine balloon catheter with 80ml of fluid to start labor in women with one previous caesarean section.

A randomized trial comparing a 30-ml and a 80-ml Foley catheter balloon for preinduction cervical ripening for women with previous LSCS requiring Induction of Labour - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004412

Enrollment

154

Registered

2014-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Pregnant woman planned for induction

Interventions

Intervention1: cervical ripening with Foley catheter balloon inflated with 30ml of sterile saline: To compare the efficacy of cervical ripening with Foley catheter balloon inflated with 30ml saline wi

Eligibility

Inclusion criteria

Inclusion criteria: Previous one LSCS, singleton pregnancy in cephalic presentation and gestational age 34 plus 6 weeks or more requiring induction of labour

Exclusion criteria

Exclusion criteria: All contraindication for trial of scar Women not willing for vaginal birth after caesarean, previous endometritis, previous pregnancy interval less than 18 months, previous extension of incision or myomectomy scar and EFW 4 kgs or more

Design outcomes

Primary

Measure	Time frame
Vaginal deliveryTimepoint: 24 hours	—

Secondary

Measure	Time frame
Effectiveness Change in Bishop score, need for oxytocin augumentation Complications Uterine hyperstimulation with FHR change, chorioamnionitis,meconium stained liquor, apgar score less than 7 at 5 min, need for NICU admission, postpartum fever or endometritis, serious maternal outcomes, neonatal sepsis Satisfaction Caregiver and mother not satisfiedTimepoint: As above	—

Countries

India

Contacts

Public ContactDr Jiji Mathews

Christian Medical College and Hospital

manpushp05@gmail.com04162283387

Outcome results

None listed

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