Placement of the inflated transcervical Foley catheter for 6 compared with 12 hours in labour induction of women with previous childbirth
| ISRCTN | ISRCTN99979127 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99979127 |
| Secondary identifying numbers | 2021107-10661 |
- Submission date
- 14/01/2022
- Registration date
- 18/01/2022
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Approximately 20–25% of pregnant women undergo induction of labour (IOL) for a variety of reasons with many requiring cervical ripening (softening of the cervix necessary for cervical opening) because the cervix is still closed.
Time to delivery from the start of IOL is an important consideration because the longer that takes, usually the risk of caesarean delivery, heavy vaginal bleeding after birth, infections in both mother and baby are higher and mothers’ satisfaction with the IOL is reduced.
Mechanical induction particularly with the single-balloon Foley catheter (an inserted tube used to inflate a baloon) is widely used as the primary IOL method. Studies have compared placement for 6 vs 12 hours placement with the use of a double balloon catheter, finding that 6-hour placement results in a quicker delivery.
The aim of the study is to evaluate 6 hours compared to 12 hours placement of the single balloon Foley catheter, solely in women who had previous vaginal childbirth on duration to delivery and maternal satisfaction with the IOL regimen.
Who can participate?
Women at term, scheduled for IOL, aged 18 years and above with prior vaginal childbirth.
What does the study involve?
The Foley catheter is usually inserted through the cervix into the lower womb. The balloon near the tip is then inflated with 80 ml of sterile water. After the Foley catheter balloon has been inflated and retained, the external tubing of the Foley catheter will be taped without tension to the inner aspect of the thigh. Once the Foley balloon is in place and a normal fetal heart rate tracing is obtained, the random allocation of intervention will be carried out. Participants have an equal chance of being assigned to either Foley placement followed by removal at
A) 6 hours or
B) 12 hours
In the interim, management is passive and expectant unless clinical developments warrant intervention.
What are the possible benefits and risks of participating?
A shorter time placement before removal of the Foley catheter may shorten the interval to birth. Apart from the time to birth, the study is not anticipated to materially impact other mother or baby outcomes.
Major complications attributable to the interventions are not anticipated. Despite balloon ripening, most women who have given birth vaginally previously will still require the breaking of waters and also a hormone drip to initiate contractions and start labour.
Participants allocated to 6-hour removal may find that their cervix might not have ripened sufficiently to allow their waters to be broken and further ripening is needed. There are various options available in this situation.
Where is the study run from?
University Malaya Medical Center, Malaysia
When is the study starting and how long is it expected to run for?
September 2021 to April 2023
Who is funding this study?
Department of Obstetrics and Gynaecology, Faculty of Medicine, University Malaya, Malaysia
Who is the main contact?
1. Dr Nadiah Kamarudzman
nadiah.k@ummc.edu.my
2. Prof Tan Peng Chiong
pctan@um.edu.my
3: Prof Datuk Dr Siti Zawiah binti Omar
szawiah@ummc.edu.my
Contact information
Principal Investigator
69, Jalan Burung Sintar
Taman Bukit Maluri
Kepong
Kuala Lumpur
52100
Malaysia
 ORCID ID |
0000-0001-8295-848X |
|---|---|
| Phone | +60 19-3359708 |
| nadiahkamarul@hotmail.com |
Principal Investigator
Pusat Perubatan Universiti Malaya
Jln Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +6012-3052970 |
| tanpengchiong@yahoo.com |
Principal Investigator
Pusat Perubatan Universiti Malaya
Jln Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0003-1646-9869 |
|---|---|
| Phone | +60 192428810 |
| szawiah@ummc.edu.my |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40940 PIS v3.0 07Oct2021.pdf |
| Scientific title | 6 hours vs 12 hours of Foley’s catheter placement for labour induction in multiparous women with unripe cervices: a randomised trial |
| Study acronym | FOLIM |
| Study objectives | Induction of labour with Foley catheter planned removal at 6 compared to 12 hours will shorten the interval to delivery and increase maternal satisfaction. |
| Ethics approval(s) | Approved 03/01/2022, University of Malaya Medical Centre Medical Research Ethics Committee (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60379498473; ummc-mrec@ummc.edu.my), ref: MREC ID: 2021107-10661 |
| Health condition(s) or problem(s) studied | Induction of labour |
| Intervention | Parous women at term with unripe cervixes and who had Foley catheter inserted trans-cervically and its balloon inflated for induction of labour will be randomized to scheduled catheter removal at A) 6 hours or B) 12 hours After the insertion of the Foley catheter to its scheduled removal, the management is typically passive and expectant. Interim vaginal assessment and tugging of the Foley catheter to expedite expulsion are avoided. However, in the event of strong painful contractions, membrane rupture, vaginal bleeding in excess of a show, non-reassuring fetal status, maternal fever or other worrisome clinical development, then vaginal assessment, catheter removal, amniotomy, and initiation of titrated intravenous oxytocin infusion may occur as appropriate within the 6- or 12-hours trial intervention periods. If the Foley balloon is spontaneously expelled within the 6- or 12-hours trial intervention periods, standard management to push on with the induction of labour process will occur. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured after birth: 1. Foley’s catheter insertion to delivery interval (min) using patient records 2. Maternal satisfaction with the labour induction process (using an 11-point 0 to 10 visual numerical rating scale) |
| Secondary outcome measures | Measured using patient records: Maternal outcomes: 1. Requirement of induction of labour measured by Bishop score before and after intervention 2. Use of additional method for cervical ripening 3. Time to delivery after Foley’s catheter removal 4. Mode of delivery 5. Indication for caesarean section 6. Duration of oxytocin infusion 7. Blood loss during delivery 8. Third -or fourth-degree tear 9. Maternal infection before hospital discharge 10. Use of regional analgesia in labour 11. Length of hospital stay (days) 12. ICU admission before hospital discharge 13. Cardiorespiratory arrest before hospital discharge 14. Hysterectomy before hospital discharge Neonatal outcomes: 1. Apgar score at 1 and 5 minutes 2. NICU admission before hospital discharge 3. Cord pH 4. Neonatal sepsis before hospital discharge 5. Birth weight (kg) 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia before hospital discharge |
| Overall study start date | 14/09/2021 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 220 |
| Total final enrolment | 220 |
| Key inclusion criteria | 1. Multiparous women (at least 1 prior vaginal delivery of 24 weeks or more gestation) 2. Age ≥18 years 3. Term pregnancy >36 weeks gestation 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membranes 7. Reassuring fetal heart tracing 8. Absence of significant contraction ≥2 in 10 minutes 9. Successful Foley insertion for IOL 10. Bishop score ≤5 |
| Key exclusion criteria | 1. History of caesarean delivery, hysterotomy, uterine perforation or myomectomy 2. Latex allergy 3. Estimated Fetal weight <2kg or >4kg 4. Known fetal major malformations 5. Contraindication for vaginal delivery 6. Patient who is suspected to have Covid 19 infection or SARS-CoV-2 positive |
| Date of first enrolment | 24/01/2022 |
| Date of final enrolment | 30/04/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Jln Profesor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +60 379494422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | http://www.ummc.edu.my/# |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high impact peer-reviewed journal. |
| IPD sharing plan | The raw data generated during and/or analyzed during the current study are/will be available upon request from Nadiah Kamarudzman (nadiah.k@ummc.edu.my) subject to the approval of the institutional review board. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 07/10/2021 | 18/01/2022 | No | Yes |
| Protocol file | version 2.0 | 13/12/2021 | 18/01/2022 | No | No |
| Participant information sheet | version 3.1 | 23/01/2022 | 24/01/2022 | No | Yes |
| Results article | 27/08/2023 | 16/06/2025 | Yes | No |
Additional files
Editorial Notes
16/06/2025: Publication reference added.
15/05/2023: The recruitment end date was changed from 30/04/2023 to 30/04/2022. Total final enrolment added.
24/01/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/01/2022 to 24/01/2022.
2. The latest version of the participant information sheet was uploaded.
18/01/2022: Trial's existence confirmed by University of Malaya Medical Centre Medical Research Ethics Committee
