Membrane sweeping or no membrane sweeping just prior to transcervical Foley catheter insertion for induction of labour in women with one previous caesarean delivery
| ISRCTN | ISRCTN87387293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87387293 |
| Secondary identifying numbers | 2019111-7979 |
- Submission date
- 03/06/2020
- Registration date
- 11/06/2020
- Last edited
- 15/12/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Caesarean delivery is the use of surgery to deliver babies. Pregnancy after a previous caesarean delivery is an increasingly common scenario. In current practice, labour is induced in at least one in five pregnancies. Trial of labour after one caesarean is standard practice. Induction of labour in women with one previous caesarean delivery is an accepted practice in well-motivated women and when conducted in an appropriate care environment with immediate access for urgent caesarean delivery. Starting labour with a Foley balloon is considered to be particularly suitable in women with one previous caesarean delivery as excessive contractions are uncommon with this method. The Foley catheter is inserted into the lower womb through the vagina and cervix and inflated to retain the balloon to allow it to gradually open the cervix. Studies have shown that membrane sweeping just before applying other methods (such as using prostaglandins, artificially rupturing membrane) hastens the birth process resulting in a quicker normal delivery. However, membrane sweeping prior to Foley catheter insertion for labour induction has not been studied in women with one previous caesarean delivery. The aim of this study is to compare transcervical Foley catheter insertion in the induction of labour of women with one previous caesarean with and without membrane sweeping in terms of the time to achieve delivery and participant’s satisfaction with their birth process. This study is important as to the researchers' best knowledge there is no information available within a clinical trial context on the effect of membrane sweeping before transcervical Foley catheter as a method of labour induction in women with a previous caesarean.
Who can participate?
Pregnant women with one previous caesarean section who are scheduled for induction of labour
What does the study involve?
Participants will be randomly allocated to one of the treatment groups: induction of labour with transcervical Foley catheter either without membrane sweeping (standard care) or with membrane sweeping. Membrane sweeping involves placing a finger into the slightly opened cervix and making a circular, sweeping movement to separate the membranes that surround the baby from the lower uterus, at the same time stretching the cervical opening. If the cervix is closed and does not permit the finger to be inserted, the cervix will be massaged instead. The Foley catheter is usually inserted digitally (a vaginal speculum can be used if digital insertion is unsuccessful) into the lower womb. The balloon near the tip is then inflated with 60 ml of sterile water. The catheter will be kept for up to 24 hours, after which the balloon will be deflated and the catheter removed if not already expelled.
What are the possible benefits and risks of participating?
There may or may not be any benefit to participants as it is not known whether membrane sweeping with Foley catheter balloon labour induction is more effective than Foley catheter balloon alone in women who have one previous caesarean delivery. Membrane sweeping can cause some pain, provoke usually self-limiting mild vaginal bleeding or uncommonly may cause the water bag to rupture (this is not a problem as breaking the water bag is part of inducing labour, but alternative methods to balloon insertion will be applied if this happens). Major complications are not anticipated. Membrane sweeping is routinely offered as standard outpatient care to women at full term to help initiate labour and also when labour is being formally induced in combination with other induction methods.
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 2019 to December 2021
Who is funding the study?
University Malaya Medical Centre (Malaysia)
Who is the main contact?
Dr Vilasini Devi d/o Magalingam
vilash86@hotmail.com
Contact information
Scientific
No.11, Jalan Sunway 6/5
Fasa 6, Bandar Sunway Semenyih
Semenyih
43500
Malaysia
| Phone | +60 (0)167114063 |
|---|---|
| vilash86@hotmail.com |
Scientific
Obstetrics and Gynaecology Department
Women and Children Health Complex
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 (0)123052970 |
| pctan@um.edu.my |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Transcervical Foley catheter with and without adjunctive membrane sweeping for induction of labour in women with one previous caesarean delivery: a randomized trial |
| Study objectives | Adjunctive membrane sweeping just prior to transcervical Foley catheter insertion for induction of labour (IOL) in women with one previous caesarean delivery will shorten the induction to delivery interval and will increase maternal satisfaction with the delivery process. |
| Ethics approval(s) | Approved 28/02/2020, University Malaya Medical Centre Medical Research Ethics Committee (MREC) (University Malaya Medical Centre, Lembah Pantai, 59100, Kuala Lumpur, Malaysia; +60 (0)3-79494422; ummc@ummc.edu.my), no ref provided |
| Health condition(s) or problem(s) studied | Induction of labour in women with one previous caesarean delivery and unripe cervix |
| Intervention | Randomisation will be done with the opening of the lowest available numbered sealed opaque envelopes in strict order. Random blocks of 4 or 8 will be used. Randomisation sequence will be generated using random.org by an investigator not involved in recruitment. Opened unassigned envelopes will be discarded. Eligible subjects will be randomly assigned to one of the treatment groups: First arm: IOL with transcervical Foley catheter without membrane sweeping (standard care) Second arm: IOL with transcervical Foley catheter with membrane sweeping Membrane sweeping involves placing a finger into the slightly opened cervix and making a circular, sweeping movement to separate the membranes that surround the baby from the lower uterus, at the same time stretching the cervical opening. If the cervix is closed and does not permit the finger to be inserted, the cervix will be massaged instead. The Foley catheter is usually inserted digitally (a vaginal speculum can be used if digital insertion is unsuccessful) into the lower womb. The balloon near the tip is then inflated with 60 ml of sterile water. The catheter will be kept for up to 24 hours, after which the balloon will be deflated and catheter removed if not already expelled. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Induction to delivery interval: the duration from foley catheter insertion to delivery time 2. Maternal satisfaction with the delivery process assessed using a 10 cm visual numerical rating scale (scored from 0 to 10) post-delivery in the postnatal ward before discharge |
| Secondary outcome measures | Maternal outcome measures, obtained from patients medical record at delivery: 1. Mode of delivery such as spontaneous vaginal delivery/Caesarean delivery and its indication and instrumental delivery (forceps and vacuum) and its indication 2. Use of additional method for cervical ripening e.g. prostaglandin use or repeat Foley catheter 3. Spontaneous rupture of membrane or amniotomy 4. Duration of oxytocin use - from time oxytocin started to stopped in hours and minutes 5. Epidural analgesia in labour - whether used or not 6. Estimated delivery blood loss - in ml 7. Fever - temperature in degree Celcius 8. Major harms e.g. severe postpartum haemorrhage (more than or equal 1500 ml), uterine rupture and admission to the intensive care unit Neonatal outcome measures, obtained from patients medical record at delivery: 1. Apgar score at 1 and 5 minutes 2. Umbilical cord arterial blood pH and base excess 3. Neonatal admission and indication |
| Overall study start date | 01/10/2019 |
| Completion date | 31/12/2021 |
| Reason abandoned (if study stopped) | During interim analysis noted that two participants in the intervention arm sustained major harms. Two patients had major harms in swept group where one had uterine rupture and the other one had massive postpartum haemorrhage secondary to cervical tear. The major harms were reported to our trial safety monitoring committee and although judged not to be attributable to trial intervention of adjunctive membrane sweeping, an interim data analysis ordered. The interim analysis indicated that further data accrual was likely to be futile on the primary outcomes and the trial was stopped. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 110 |
| Total final enrolment | 63 |
| Key inclusion criteria | 1. Scheduled for labour induction 2. One previous caesarean section 3. Unripe cervix (Modified Bishop Score ≤ 5) 4. 18 years and above 5. Singleton pregnancy 6. 37 weeks gestation and above 7. Cephalic presentation 8. Reassuring fetal heart rate tracing 9. Absence of significant contraction ≥ 2 in 10 minutes |
| Key exclusion criteria | 1. Contraindication to vaginal delivery 2. Known gross fetal anomaly 3. Ruptured membranes 4. Latex allergy 5. Fetal weight clinically estimated to be ≤ 2 kg or ≥ 4kg, then confirmed by ultrasound 6. Preference for repeat Caesarean delivery |
| Date of first enrolment | 18/06/2020 |
| Date of final enrolment | 31/12/2021 |
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 79494422 |
|---|---|
| ummc@ummc.edu.my | |
| Website | https://www.ummc.edu.my/ |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Study protocol is not published. The researchers plan to publish their trial data as an article in a journal listed in the ISI Web of Science. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. Only the investigators will access to the research data. Anonymised (where individuals cannot be identified) trial data may be released to other researchers in the future as permitted by the ethics committee. |
Editorial Notes
15/12/2021: Internal review. The study was terminated prematurely on 08/12/2020. The total final enrolment number has been added.
01/07/2020: The recruitment start date was changed from 30/06/2020 to 18/06/2020.
09/06/2020: Trial's existence confirmed by University Malaya Medical Centre Medical Research Ethics Committee (MREC).
