Imaging of the birth canal opening during labour as a pushing aid among first-time mothers
| ISRCTN | ISRCTN57404917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57404917 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2021105-10643 |
| Sponsor | University Malaya Medical Centre |
| Funder | Universiti Malaya |
- Submission date
- 20/11/2021
- Registration date
- 23/11/2021
- Last edited
- 23/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
We plan to evaluate whether the real-time video of the mother as visual biofeedback in addition to standard healthcare provider verbal coaching can impact the time it takes to push the baby out and maternal satisfaction.
Who can participate?
Pregnant women aged more than 18 years old who have no previous pregnancy beyond 20 weeks and who is planning for vaginal delivery.
What does the study involve?
During pushing, half of participants will be provided with a display screen showing their birth canal opening or face in order to help and motivate them to push more effectively. The other half will proceed as usual.
What are the possible benefits and risks of participating?
Effective visual feedback may shorten pushing time and increase maternal satisfaction.
Major complications are not anticipated. Visual feedback may prove to be a distraction rather than a help.
Where is the study run from?
Labour room of University Malaya Medical Center (UMMC) (Malaysia)
When is the study starting and how long is it expected to run for?
August 2021 to February 2023
Who is funding the study?
Department of Obstetrics and Gynaecology, UMMC (Malaysia)
Who is the main contact?
Dr Noor Ashikin
ashikin.hamid@ummc.edu.my
Contact information
Scientific
494, Jalan Cengal 1/19
Taman Cengal Indah 2
Kulim
09000
Malaysia
| Phone | +60 (0)124842969 |
|---|---|
| ashikin.hamid@ummc.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre open-label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 40698 PIS v1.0 07Oct2021.pdf |
| Scientific title | Real-time imaging as visual biofeedback in active second stage of labour among nulliparas women: a randomised controlled trial |
| Study acronym | RIVBASSLAN |
| Study objectives | Nulliparas women who utilized visual biofeedback of the maternal introitus compared to the maternal face (sham/placebo) are more likely to have shorter duration of active second stage of labour and higher satisfaction with pushing experience during birth |
| Ethics approval(s) | Approved 20/10/2021, Medical Research Ethics Committee (University of Malaya Medical Centre, Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60 (0)3-79493209; no email provided), ref: 2021105-10643 |
| Health condition(s) or problem(s) studied | Childbirth |
| Intervention | Patients admitted to the ward for planned vaginal delivery and who study criteria will be approached for recruitment. Written informed consent will be taken. Once participants are about to start the active second stage of labour, they will be randomised to biofeedback or sham/placebo control by the opening of the lowest numbered sealed opaque envelope remaining to reveal the allocated intervention. Patients allocated to the study group will be using visual biofeedback during her second stage of labour. A video camera will be placed on a stand at the end of the bed with the maternal introitus in focus and a display monitor on a stand will be placed next to the bedside in clear view of the participant Patients in the control group will be coached during the second stage as per standard care. The display monitor of the participants in the control group will show their face during the second stage. All participants are asked to watch the display screen carefully during pushing and listen to the standard verbal coaching that will be given to all participants by the care providers conducting the delivery. In synchronization with the uterine contraction, participants will be encouraged to bear down while observing the movement of the fetal head on introitus the display screen, thus receiving visual biofeedback of her pushing effort. The live feed video streaming from camera to display will not be captured or recorded Demographic data are transcribed onto the Case Report Form The participants’ electronic hospital records will be retrieved to obtain maternal and neonatal outcome data. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Measured using patient records at the end of the study: |
| Key secondary outcome measure(s) |
Measured using patient records at the end of the study: |
| Completion date | 01/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 220 |
| Key inclusion criteria | 1. Nulliparous 2. Age ≥18 years 3. Singleton pregnancy 4. Cephalic presentation 5. No contraindication for vaginal delivery 6. Reassuring fetal status (normal fetal heart rate tracing) 7. About to commence pushing |
| Key exclusion criteria | 1. Patient who is suspected COVID 19 infection or COVID 19 positive 2. Known gross fetal anomaly 3. Planned instrumental delivery to shorten second stage 4. Maternal severe visual impairment 5. History of maladaptive maternal response to visual stimuli provoking e.g., migraine, seizure |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
59100
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Noor Ashikin (ashikin.hamid@ummc.edu.my) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 07/10/2021 | 23/11/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.0 | 07/10/2021 | 23/11/2021 | No | No |
Additional files
- 40698 Protocol v1.0 07Oct2021.pdf
- Protocol file
- 40698 PIS v1.0 07Oct2021.pdf
- Participant information sheet
Editorial Notes
23/11/2021: Trial's existence confirmed by Medical Research Ethics Committee, University of Malaya Medical Centre.
