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Comparison of single balloon catheter versus Double balloon catheter for cervical softening in nulliparous women

Comparison of single foleys catheter versus Double foleys catheter for cervical ripening in nulliparous women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049712
Enrollment
100
Registered
2023-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery Health Condition 2: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Double foleys catheter device: Two 14F Foleys tied together with 1-0 silk at two points- first through the distal holes of foleys and second distal to the balloon of foleys. Post insert

Sponsors

Maulana Azad medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: nulliparous gestational age 37-41 weeks singleton gestation cephalic presentation Bishop score intact membranes

Exclusion criteria

Exclusion criteria: contraindication to vaginal delivery scarred uterus non reassuring fetal heart rate intrauterine death Diabetes mellitus

Design outcomes

Primary

MeasureTime frame
1)Change in Bishops score in Single Foleys Catheter versus Double Foleys catheter at spontaneous expulsion or after removal 2)Proportion of women with successful cervical ripening(successful cervical ripening increase in Bishops score 2 or more or Bishops score of more than or equal to 6 following balloon expulsion or device removal within 12 hours.Timepoint: 1)Change in Bishops score in Single Foleys Catheter versus Double Foleys catheter at spontaneous expulsion or after removal 2)Proportion of women with successful cervical ripening(successful cervical ripening increase in Bishops score 2 or more or Bishops score of more than or equal to 6 following balloon expulsion or device removal within 12 hours.

Secondary

MeasureTime frame
Caesarean section due to failure of inductionTimepoint: Insertion to expulsion time Insertion to delivery time

Countries

India

Contacts

Public ContactDr Sowmiya K

Maulana Azad medical college

drsangeetamamc@gmail.com8368199481

Outcome results

None listed

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