Randomised controlled trial of comparison of prostaglandin gel insertion versus Foleys catheter insertion into birth canal as a means of artificially starting the process of labour after 37 weeks of pregnancy.

COMPARATIVE STUDY OF INTRA-CERVICAL PGE2 GEL VERSUS TRANS CERVICAL FOLEYâ??S CATHETER BALLOON FOR INDUCTION OF LABOUR AT TERM- A RANDOMISED CONTROL TRIAL.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032581

Enrollment

150

Registered

2021-04-06

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: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: TRANS CERVICAL FOLEYâ??S CATHETER BALLOON: GROUP B (FOLEYâ??S CATHETER METHOD) Under aseptic precautions no.16 size Foleyâ??s catheter will be introduced through the c

Eligibility

Inclusion criteria

Inclusion criteria: Patients requiring induction of labour with 1. Singleton pregnancy 2. 37weeks-42 weeks of gestation 3. Clinically adequate pelvis 4. Bishopâ??s score 5. Intact fetal membranes 6. Fetus in cephalic presentation

Exclusion criteria

Exclusion criteria: 1. Multifetal pregnancy 2. Malpresentation 3. Antepartum hemorrhage 4. Scarred uterus 5. Estimated fetal weight >4 kg 6. Chorioamnionitis. 7. Major congenital anomalies in fetus 8. Any indication for immediate caesarean section

Design outcomes

Primary

Measure	Time frame
Mode of delivery Change in Bishopâ??s score Induction-delivery intervalTimepoint: At delivery In labour- at pelvic examination for reassessment of cervical status At delivery	—

Secondary

Measure	Time frame
Indication for induction Need for augmentation Low APGAR score at birth NICU (Neonatal intensive care unit) admission NICU length of stayTimepoint: Prior to induction At reassessment of cervical status Immediately after delivery 3 days after delivery	—

Countries

India

Contacts

Public ContactTahmina S

Melmaruvathur Adhiparasakthi Institute of Medical Sciences & Research

dr.tahmina.s@gmail.com8870730885

Outcome results

None listed

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