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NCT05885087

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

Completed NA Last updated 1 June 2023
What this trial tests

NA trial testing Foley or balloon catheter in Labor, Induced in 20 participants. Completed in 1 September 2022.

Timeline
1 February 2022
Primary endpoint
1 August 2022
1 September 2022

Quick facts

Lead sponsorUniversity of Botswana
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 February 2022
Primary completion1 August 2022
Estimated completion1 September 2022
Sites1 location across Botswana

Drugs / interventions tested

Conditions studied

Sponsor

University of Botswana

Who can join

Adults 18 to 45, female only, with Labor, Induced. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Extended balloon labour induction: A single arm proof of concept trial.
    Matshitsa L, Mercy-Nkuba N, Hofmeyr GJ. · · 2023 · cited 1× · PMID 37649714 · DOI 10.1016/j.eurox.2023.100226

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Other recruiting trials for Labor, Induced

Currently open trials in the same condition.

Other University of Botswana trials

Trials by the same sponsor.

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Data sources for this page

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