'Extended Balloon Catheter' Labour Induction; a Single Arm Pilot Trial'

NCT05885087 | Completed

• 1 other identifier: UBR/RES/IRB/BIO/GRAD/145
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the single arm pilot study was to assess the effectiveness, safety and acceptance of the 'extended balloon catheter' as a method of induction of labour in women receiving care at Princess Marina Hospital(PMH) in Gaborone, Botswana. The main questions it aimed to answer were whether 'extended balloon catheter' is an effective method of labour induction, whether it results in increased adverse events for the mother and baby and whether it is associated with increased mother satisfaction. Participants were assessed as having a favourable cervix using the modified Bishop score of equal to or more than 7. Three Foley balloon catheters attached side by side were inflated with 60mls each and a gentle traction of 250mls water applied. Delivery interval (time of induction to time of delivery), mode of delivery and Apgar scores were recorded. Adverse maternal and neonatal outcomes were recorded. Participants' satisfaction with the method of induction was assessed using a descriptive scale.

Conditions

Labor, Induced

Keywords

foley/balloon catheter; labor induction; favorable cervix

Outcome Measures

Primary Outcomes (1)

• Successful labor induction

  Successful labor induction defined as vaginal birth within 60 hours.

  Enrolment until 60 hours

Secondary Outcomes (2)

• Adverse event

  Enrolment until discharge from hospital, or up to 2 weeks

• Acceptability

  Enrolment until discharge from hospital, or up to 2 weeks

Study Arms (1)

Foley/Balloon catheter arm

EXPERIMENTAL

Participants were assessed as having a favourable cervix using the modified Bishop score of equal to or more than 7. Three Foley balloon catheters attached side by side were inflated with 60mls each and a gentle traction of 250mls water applied.

Device: Foley or balloon catheter

Interventions

Foley or balloon catheter DEVICE

Three Foley balloon catheters attached side by side were inflated with 60mls each and a gentle traction of 250mls water applied.

Foley/Balloon catheter arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 years or older without serious morbidity due for labour induction, who give consent to participate.
• Cervix considered too far dilated to retain a single balloon, or single balloon has fallen out while not yet in labour.
• Bishop score of equal or more than 7.
• Nulliparous and multiparous
• Singleton and cephalic
• Gestation \>37+0 weeks
• Estimated fetal weight \<4kg

You may not qualify if:

• Previous caesarean delivery
• Very urgent labour induction indications (eg eclampsia, preeclampsia with severe features)
• Ruptured membranes

Sponsors & Collaborators

• University of Botswana: lead

Study Sites (1)

Princess Marina Hospital

Gaborone, South-East District, 267, Botswana

Location

Study Officials

• JUSTUS HOFMEYR, DSc

  University of Botswana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of Obstetrics and Gynecology

Model Details: single group prospective trial

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 1, 2023
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: within 5 years after study completion.
• Access Criteria: reasonable request in the context of an approved protocol

Locations

BO (1)