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

NCT05885087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-01

No results posted yet for this study

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

Interventions

DEVICE

Foley or balloon catheter

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

Sponsors & Collaborators

  • University of Botswana

    lead OTHER

Principal Investigators

  • JUSTUS HOFMEYR, DSc · University of Botswana

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-08-01
Completion
2022-09-01

Countries

  • Botswana

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885087 on ClinicalTrials.gov