Tugging the balloon every three hours to check for dislodgement during the Foley catheter labour induction of women who had previously given birth

Plain English Summary

Background and study aims
Induction of labour is very common, involving about a quarter of pregnancies at term. The single-balloon Foley catheter is widely used as the primary method for labour induction when the neck of the womb (cervix) is unripe for the mechanical ripening of the cervix due to its low cost and low risk of overstimulating the womb (uterus) compared to drugs like prostaglandins and oxytocin. After the catheter has been placed through the cervix into the lowest part of the uterus and its balloon inflated to 30 ml with water, the standard practice is to wait up to 12 hours for the balloon to be spontaneously expelled out of the vagina after the cervix has ripened (partially opened to allow the balloon to pass through). After balloon expulsion, the forewater is broken and oxytocin drip started to initiate contraction pain for the labour to proceed. After the cervix has opened sufficiently to allow passage of the Foley balloon, the spontaneous passage down the vaginal leading to the expulsion of the balloon can take time (possibly hours). This delay in the breaking of the forewaters and the start of the oxytocin, delay labour contraction pain and delivery. By tugging the Foley catheter periodically every three hours to check for balloon dislodgement through the cervix, any dislodgement can be detected earlier, allowing for the timely breaking of the forewaters and start of the oxytocin drip hastening labour contraction pain and hence, expediting delivery. We anticipate that periodic gentle tugging will be well tolerated. A lengthy labour induction process adversely impacts maternal satisfaction and can increase healthcare costs.

Who can participate?
Labouring adult women who are being induced and have had a successful Foley catheter insertion

What does the study involve?
Following the placement of the Foley catheter balloon in the cervix for labour induction, the patients will either be in a group that receives tugging of the balloon every three hours to check for dislodgement or standard care (no tugging) while awaiting spontaneous expulsion of the Foley balloon.

What are the possible benefits and risks of participating?
Three hourly tugging of Foley catheter may shorten the interval to birth and improve maternal satisfaction with their labour induction. The study intervention is not anticipated to materially impact on other mother or baby outcomes. Major complications are not anticipated. The Foley catheter tugging may be uncomfortable or even painful (tugging will cease on participants’ instruction). It is possible that following catheter dislodgement after tugging (or removal after standard 12 hours) the cervix may not be sufficiently opened for breaking of the forewaters. In this instance, other methods for ripening will be available from your care provider.

Where is the study run from?
The University Malaya Medical Center (UMMC) (Malaysia)

When is the study starting and how long is it expected to run for?
May 2022 to August 2023

Who is funding the study?
UMMC (Malaysia)

Who is the main contact?
1. Dr Noor Fadzliana Binti Mohd Zin (Affiliation Medical Officer Obstetrics and Gynaecology) (Malaysia), fadzliana_86@yahoo.com
2. Prof Tan Peng Chiong (Affiliation Consultant in Obstetrics and Gynaecology) (Malaysia), pctan@um.edu.my
3. Prof Datuk Dr Siti Zawiah binti Omar (Affiliation Consultant in Obstetrics and Gynaecology) (Malaysia), szawiah@um.edu.my

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Malaysia

Study participating centre

Sponsor information

University of Malaya
University/education

Department of Obstetrics &Gynaecology
Kompleks Kesihatan Wanita & Kanak-kanak
University Malaya Medical Center
Jalan Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia

Phone	+60379494422
Email	ummc@ummc.edu.my
Website	https://www.um.edu.my/
"ROR"	https://ror.org/00rzspn62

Funders

Funder type

University/education

Results and Publications

Study outputs

Additional files

42767 PIS v1.0 14Sept2022.pdf

42767 Protocol v1.0 14Sept2022.pdf

Editorial Notes

07/04/2025: Internal review.
04/04/2025: The following changes were made to the trial record:
1. The recruitment start date was changed from 5/12/2022 to 7/12/2022.
2. The overall end date was changed from 01/08/2023 to 03/08/2023.
25/09/2024: The recruitment end date was changed from 15/12/2023 to 01/08/2023.
24/09/2024: The overall study end date was changed from 15/12/2023 to 01/08/2023. IPD sharing plan added.
20/09/2024: The following changes were made to the trial record:
1. The ethics approval date was changed from 01/11/2022 to 19/10/2022.
2. The overall end date was changed from 31/12/2023 to 15/12/2023.
05/12/2023: The total final enrolment was added.
08/12/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/12/2022 to 05/12/2022.
2. The participant level data sharing statement was added.
23/11/2022: Trial's existence confirmed by the Medical Research and Ethics Committee University Malaya Medical Center.