Placing the Foley balloon catheter adjacent to the inner portion of the neck of the womb to induce labour in women at their first delivery followed by waiting in the hospital or at home
| ISRCTN | ISRCTN18100609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18100609 |
- Submission date
- 14/05/2024
- Registration date
- 22/05/2024
- Last edited
- 20/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In the United Kingdom, the rate of induction of labour (IOL) has increased from 18.3% in 1989-90 to 34.4% by 2020-2, indicating that IOL is increasingly common. In about 70% of IOL cases, mechanical or pharmacological intervention is needed to ripen (open up) the closed cervix. For patients undergoing their first delivery and whose cervix is unripe, the time from induction to birth takes longer and their risk of needing a caesarean is higher. Balloon catheters for IOL are recommended by the WHO (World Health Organisation). They lead to fewer problems for the baby as they usually do not cause contraction pain as they ripen the cervix and are suitable for outpatient use. Available evidence shows that outpatient (with some of the initial ripening time spent at home) IOL is as effective and safe as inpatient (the whole time from the start of the process spent in hospital) IOL. Mothers’ satisfaction is also similar with either inpatient or outpatient IOL as a method but the amount of evidence is limited at present. Currently, inpatient Foley balloon IOL is the usual care at the Department of Obstetrics and Gynecology, Faculty of Medicine, University Malaya, Malaysia. The WHO and international experts consider women’s experience during childbirth as a critical aspect of high-quality care during childbirth. It is important to explore ways in which the IOL may be managed as acceptably for women as possible. Satisfaction of outcome arising from choice is strongly linked to the process involved in making the choice and if the outcome is positive. However, the impact when patients exercise their free will and make a choice about their care, on their eventual satisfaction with that care, compared to when the same care is delivered as part of standard practice (without conscious selection), has not been explored in a clinical study. This study evaluates in-hospital compared to at-home Foley ripening for labour induction and the impact when patients are allowed to choose or when they are randomly assigned to hospital or at-home IOL.
Who can participate?
Adult women scheduled Foley balloon labour induction
What does the study involve?
This study involves an assessment of mothers’ satisfaction based on exposure to in-hospital or at-home IOL and also of the role that maternal choice may play in decision-making in impacting maternal satisfaction with labour induction.
About half of those participating who accept to be assigned to one of the two trial interventions (only after a successful Foley balloon insertion) of
1. Remaining in the hospital to passively wait for 24 hours for the cervix to ripen (partially open) before further assessment
If not spontaneously expelled before 24 hours, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy
OR
2. Going home to passively wait for 24 hours for the cervix to ripen before returning to the hospital at 8 am the following day for an assessment
A written instruction leaflet will be provided in the event of anticipated developments at home that would require an earlier return to the hospital. In the hospital, if not spontaneously expelled, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy
About half of those participating who expressed a preference will choose (after a successful Foley balloon), by their own will
1. Remain in the hospital to passively wait for 24 hours for the cervix to ripen (partially open) before further assessment
If not spontaneously expelled before 24 hours, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy
OR
2. Go home to passively wait for 24 hours for the cervix to ripen before returning to the hospital at 8 am the following day for an assessment
A written instruction leaflet will be provided in the event of anticipated developments at home that would require an earlier return to the hospital. In the hospital, if not spontaneously expelled, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy
What are the possible benefits and risks of participating?
Mothers’ satisfaction with the IOL may or may not be higher as a result of in-hospital vs. at-home Foley IOL (current limited evidence suggests they will be similar). Mothers’ satisfaction also may or may not be higher as being able to choose in-hospital vs. at-home Foley IOL. In-hospital IOL may be quicker to birth from insertion of the Foley balloon, however, in contrast, the total time spent in the hospital from Foley balloon insertion to birth may be shorter because some of the time is spent at home.
Major complications such as caesarean birth or the baby being born in a poor condition arising from the interventions are not anticipated, as guided by the available data.
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?
October 2023 to April 2025
Who is funding the study?
Department of Obstetrics and Gynecology, Faculty of Medicine, University Malaya, Malaysia
Who is the main contact?
Norsyahirah Abd Razad, s2031073@siswa.um.edu.my, norsyahirahabdrazad@yahoo.com
Contact information
Public, Scientific, Principal Investigator
University Malaya Medical Centre, Jalan Professor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +60122456389 |
|---|---|
| s2031073@siswa.um.edu.my |
Principal Investigator
University Malaya Medical Centre, Jalan Professor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +60379492049 |
|---|---|
| tanpengchiong@yahoo.com |
Principal Investigator
University Malaya Medical Centre, Jalan Professor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +603-7949 2110 |
|---|---|
| farah.faizg@ummc.edu.my |
Principal Investigator
Jalan Professor Diraja Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +603-7949 2110 |
|---|---|
| thai.wong@um.edu.my |
Study information
| Study design | Single-centre parallel-design pragmatic randomized controlled trial study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Inpatient vs outpatient Foley catheter induction in nulliparas: a pragmatic randomized controlled trial |
| Study objectives | Following placement of the Foley balloon for cervical ripening in the induction of labour of women at their first delivery, 1) waiting in the hospital or at home for up to 24 hours, 2) as randomly assigned or by maternal choice, both options will affect maternal satisfaction of their labour induction experience. The hypotheses are: 1. Inpatient vs outpatient will result in higher maternal satisfaction with the Foley balloon IOL 2. By choice vs as randomised will result in higher maternal satisfaction with the Foley balloon IOL 3. Inpatient by choice vs. inpatient as randomized will result in higher maternal satisfaction with the Foley balloon IOL 4. Outpatient patient by choice vs. outpatient as randomized will result in higher maternal satisfaction with the Foley balloon IOL |
| Ethics approval(s) |
Approved 12/05/2024, University of Malaya Medical Centre Medical Research Ethics Committee (2nd floor, Kompleks Pendidikan Sains Kejururawatan, Pusat Perubatan Universiti Malaya, 59100, Malaysia; +603-79493209/2251/8473/4656; ummc-mrec@ummc.edu.my), ref: 2024221-13445 |
| Health condition(s) or problem(s) studied | Foley balloon labour induction |
| Intervention | All nulliparous women presenting at the induction facility of our centre for a planned induction of labour will be assessed for trial eligibility and will be counseled about this study. The patient information sheet will provided, and oral queries encouraged and responded to by the care provider doing the recruitment. Informed written consent will be obtained from all participants. About half of those participating who accept will be randomised to one of the two trial interventions (only after a successful Foley balloon insertion) of 1. Remaining in the hospital to passively wait for 24 hours for the cervix to ripen (partially open) before further assessment If not spontaneously expelled before 24 hours, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy OR 2. Going home to passively wait for 24 hours for the cervix to ripen before returning to the hospital at 8 am the following day for an assessment A written instruction leaflet will be provided in the event of anticipated developments at home that would require an earlier return to the hospital. In the hospital, if not spontaneously expelled, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy About half of those participating who expressed a preference will choose (after a successful Foley balloon), by their own will 1. Remain in the hospital to passively wait for 24 hours for the cervix to ripen (partially open) before further assessment If not spontaneously expelled before 24 hours, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy OR 2. Go home to passively wait for 24 hours for the cervix to ripen before returning to the hospital at 8 am the following day for an assessment A written instruction leaflet will be provided in the event of anticipated developments at home that would require an earlier return to the hospital. In the hospital, if not spontaneously expelled, the balloon will be removed to assess that the cervix sufficiently ripened for amniotomy Standard induction care will be applied at all times. When the cervix has ripened, amniotomy and starting titrated oxytocin infusion in furtherance of achieving labour and birth will be performed. Randomisation is through the opening of the lowest number, sealed and opaque envelope that is available for the latest recruit. The randomisation sequence will be generated by an online randomiser in random blocks of 4 or 8 by an investigator who is not involved in trial enrolment. Blinding is not feasible due to the nature of the intervention and the design of the study. During the hospital stay, participants will receive standard care including periodic monitoring of the mother and baby, indicated prophylactic measures and treatments for induction, labour and delivery, arrangements for hospital discharge and postpartum follow-up. Women will be positioned in the dorsal lithotomy position. A Foley catheter size 16F is introduced through the outer cervical canal using either the digital or speculum method (at the discretion of the introducer). Once the tip of the catheter passes the internal os, the catheter will be inflated with 60 mL of water and then retracted so that the balloon rests on the cervical os and the external end of the Foley catheter will be taped without tension to the medial aspect of the women’s thigh. Fetal monitoring will be performed immediately after the inflation of the balloon catheter. Randomisation will only be carried out once the catheter is in situ and post-foley catheter insertion CTG is normal. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The following maternal satisfaction outcomes with the Foley balloon labour induction will be measured using an 11-point (0-10) numerical rating scale (NRS) before hospital discharge: 1. Inpatient vs. outpatient 2. By choice vs randomised 3. Inpatient by choice vs. inpatient as randomised 4. Outpatient patient by choice vs. outpatient as randomised |
| Secondary outcome measures | Maternal outcomes: 1. If they would recommend their intervention of inpatient or outpatient to a friend measured using a Likert scale (5-grade) response (assessed before hospital discharge) to (strongly agree to strongly disagree) before hospital discharge 2. Cervical ripening measured using the Bishop score before and after the intervention 3. Use of additional method for cervical ripening measured using data collected in medical records at the end of the study 4. Time to delivery after Foley removal/expulsion measured using data collected in medical records at the end of the study 5. Mode of delivery measured using data collected in medical records at the end of the study: 5.1. Spontaneous vaginal 5.2. Vacuum 5.3. Forceps 5.4. Caesarean section The following outcomes are measured using data collected in medical records at the end of the study: 6. Indication for operative delivery 7. Duration of oxytocin infusion 8. Blood loss during delivery 9. Third- or fourth-degree tear 10. Maternal infection 11. Use of regional analgesia in labour (epidural) 12. Length of hospital stay 13. ICU admission 14. Cardiopulmonary arrest 15. Needing hysterectomy 16. Maternal satisfaction with the Foley balloon IOL: choice vs randomised measured using an 11-point 0-10 visual numerical rating scale (NRS) Neonatal outcomes The following neonatal outcome measures are assessed using data collected from medical records, unless stated, at the end of the study: 1. Newborn health measured using Apgar scoring at 1 and 5 minutes 2. NICU admission 3. Cord artery pH 4. Neonatal sepsis 5. Birth weight 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia |
| Overall study start date | 01/10/2023 |
| Completion date | 01/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 252 |
| Key inclusion criteria | 1. Scheduled Foley balloon labour induction 2. The patient has transport available and lives within 30 minutes of the hospital 3. The patient has a functional telephone 4. Ability to communicate in English or Malay 5. Term ≥ 37 weeks gestation 6. Singleton pregnancy 7. Nulliparous (no prior pregnancy ≥ 22 weeks) 8. Cephalic presentation 9. Reassuring fetal heart rate monitoring 10. Intact membranes 11. Unfavourable cervix (Bishop score ≤ 6) 12. Successful Foley balloon insertion |
| Key exclusion criteria | 1. Patient that contraindicated for vaginal delivery (eg: Placenta Previa, non-cephalic presentation) 2. Latex allergy 3. Fetal anomaly 4. Regular contraction of more than 2 in 10 minutes |
| Date of first enrolment | 15/06/2024 |
| Date of final enrolment | 15/03/2025 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60(0)3-7949 2110 |
|---|---|
| iresearch@ummc.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 30/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Available for institutional review board-approved individual patient data meta-analysis 12 months after publication |
Editorial Notes
20/05/2024: Study's existence confirmed by the University of Malaya Medical Centre Medical Research Ethics Committee.
