Tugging the foley's catheter every three hours in the labor induction of women with a previous caesarean section

Plain English Summary

Background and study aims
About 25% of pregnant women have their labour induced or started early for various reasons. Induction of labour after one previous cesarean is considered a high-risk procedure as the process has a significant risk of not being successful (25-50%) and a caesarean section is then needed. There is also the small risk of uterine scar rupture (about 0.5%). In well-motivated women, it is an accepted practice and considered safe when conducted in a well-resourced. If vaginal birth is achieved, both mother and baby tend to have better outcomes compared to a planned repeat caesarean but the outcome is generally the least favourable if the induction was not successful.

A mechanical method for cervical ripening at labour induction is widely used when the cervix is still closed or minimally open (unfavourable or unripe) as this method to open the cervix for the first 3-5 cm (ripening) can be achieved typically without significant pain (contractions). Once the cervix is opened to at least 3 cm, the forewater can be easily broken and the oxytocin hormone started as needed to bring on the necessary contractions to achieve the full cervical opening and ultimately the baby to be delivered normally.

The Foley catheter (a thin rubber tube with an inflatable balloon at the end) is a popular mechanical method of cervical ripening as it is effective. Complications to the baby can be fewer as this method typically does not cause contractions during ripening. The balloon can be easily inserted through feel by hand or through a speculum (a device inserted into the vagina which when opened allows for the neck of the womb to be seen) under direct view and the tube to be inserted this way. The tube is passed through the opening of the neck of the womb just into the lower womb and the balloon is then inflated to 30 ml and then pulled back slightly to rest on the inner portion of the neck of the womb. The outer end of this tube is taped to the woman’s thigh usually without tension to the balloon. This balloon placement starts the process for the neck of the womb to soften and open.

Who can participate?
Women aged 18 years or older who have previously had a caesarean section and are due to give birth.

What does the study involve?
Participants will be randomly allocated to receive either:
1. During Foley balloon cervical ripening, the catheter will be tugged intermittently, every three hours to check for dislodgement (indicating a ripened cervix) following which the balloon will be retrieved and amniotomy and titrated oxytocin infusion can commence expediting labour and delivery
OR
2. Standard care during Foley balloon cervical ripening whereby the Foley balloon will be passively left in place (no tugging) to await spontaneous expulsion. Following spontaneous expulsion with the cervix ripened, amniotomy and titrated oxytocin infusion can commence expediting labour and delivery

Standard care during labour induction, labour, delivery and after delivery will be provided to all participants

What are the possible benefits and risks of participating?
We anticipate a shorter time to birth and higher maternal satisfaction with tugging compared to standard care. The risk of tugging would be that it maybe uncomfortable, even painful. The tugging will cease if the pain is felt. Also, it is possible that tugging will dislodge the balloon through a borderline opened neck of the womb which is just not opened enough for the waters to be broken, in which case the Foley catheter needs to be re-inserted or another method used to ripen the cervix further.

Where is the study run from?
University Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
November 2022 to September 2024

Who is funding the study?
University Malaya Medical Centre (Malaysia)

Who is the main contact?
Dr Yunesh Krishnan, yunesh@ummc.edu.my

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Malaysia

Study participating centre

Sponsor information

University Malaya Medical Centre
Hospital/treatment centre

University Malaya
Jalan Profesor Diraja Ungku Aziz
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone	+60 3-79673502
Email	pen_ippp@um.edu.my
Website	http://www.ummc.edu.my/#
"ROR"	https://ror.org/00vkrxq08

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Additional files

43395 PROTOCOL v1 19Jan2023.pdf

43395 PIS v1 19Jan2023.pdf

ISRCTN16633990 Results.pdf

Editorial Notes

17/09/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/05/2023 to 01/04/2023.
2. The recruitment end date was changed from 01/08/2024 to 07/03/2024.
3. A file of unpublished results was uploaded as an additional file.
28/03/2023: Trial's existence confirmed by University of Malaya Medical Centre.