Live camera viewing by the first-time mother of the birth canal opening as a feedback aid during self-motivated pushing for normal delivery
| ISRCTN | ISRCTN94920608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94920608 |
- Submission date
- 21/10/2024
- Registration date
- 21/10/2024
- Last edited
- 03/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Getting live visual cues from self-observation of the birth canal (vaginal) opening during their pushing for normal birth can be especially helpful in first-time mothers who also are controlling their pushing. The cues derived can be processed in real-time to improve the participants’ mental and physical responses in a process called visual biofeedback. Studies have shown that mothers exposed to visual biofeedback expressed high satisfaction with their experience, their pushing is shortened and connectedness to their baby is improved. One study indicates it may reduce the risk of major childbirth-related injury to first-time mothers. First-time mothers need to push for longer to birth. Nine in 10 first-time mothers who have a vaginal birth sustain injury to the birth canal, which will probably need stitches. Directed pushing is a common practice during the second stage of labour where the healthcare provider instructs the woman to hold her breath and push during each contraction. Conversely, in spontaneous pushing, women are free to follow their instincts and generally push 3 to 5 times per contraction. A woman who uses a spontaneous pushing approach is self-directed in her bearing down technique. She may push with vocalization, using intermittent exhalation technique, or in response to an involuntary urge. These spontaneous pushing efforts vary in intensity and frequency. Studies have shown that spontaneous pushing results in at least the same maternal and newborn outcomes, lower Caesarean section rates and lower incidence of extension of the episiotomy (a cut to the birth canal opening to facilitate normal birth) but it may take longer to give birth. Studies have found that when comparing the hands-off (or poised) technique versus the hands-on technique at the point of birth resulted in a similar degree of birth canal tears. However, the hands off technique resulted in a lower incidence rate of episiotomy. This study aims to evaluate real-time visual biofeedback (using a camera-display monitor set up) trained on the first-time mother’s birth canal opening compared to the face during their spontaneous pushing on major birth-related injury.
Who can participate?
Adult first-time mothers who are to start pushing for normal birth during an uncomplicated labour.
What does the study involve?
A video camera (e.g., a GoPro camera) will be placed on a stand at the end of the bed with the maternal introitus or face (depending on random allocation) in focus and a Bluetooth-connected display monitor will be placed next to the bedside in clear view of the participant. Participants will then be allowed to push on their own accord when motivated by contractions or need to bear down sensation. They will be instructed to employ a pushing technique that they are comfortable with and modify it based on feedback that they receive from the live-view display monitor.
What are the possible benefits and risks of participating?
The plausible benefit of visual biofeedback of maternal introitus include:
1. Fewer major birth-related injury
2. Shorter duration of the active second stage of labour
3. Higher satisfaction with the birth experience
The plausible risks of visual biofeedback of maternal introitus include:
1. Major complications are not anticipated
2. May prove to be a distraction resulting in birth delay
3. Seeing a change to the birth canal opening during childbirth may cause distress
Where is the study run from?
University Malaya Medical Centre, Malaysia
When is the study starting
16 Nov 2024 (to 15 Nov 2025)
Who is funding the study?
Internally funded by the Department of Obstetrics and Gynaecology, Faculty of Medicine, University Malaya Medical Centre, Malaysia
Who is the main contact?
1. Dr Iryani Abdul Samad, eryn2410@gmail.com
2. Prof Mukhri Bin Hamdan, mukhri@um.edu.my
3. Prof Dr Tan Peng Chiong, tanpengchiong@yahoo.com
Contact information
Principal Investigator
University Malaya Medical Centre, Lembah Pantai
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0009-0001-1188-5153 |
|---|---|
| Phone | +60 0172003424 |
| eeryn2410@gmail.com |
Scientific, Principal Investigator
University Malaya Medical Centre, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0002-1006-2614 |
|---|---|
| Phone | +60 03-79492049 |
| mukhri@um.edu.my |
Public, Scientific, Principal Investigator
University Malaya Medical Centre, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 03-79492049 |
| tanpengchiong@yahoo.com |
Study information
| Study design | Single center parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Efficacy |
| Scientific title | Live visual biofeedback of maternal introitus vs maternal face during self-motivated pushing in nulliparas: a randomised controlled trial |
| Study objectives | Live viewing of the maternal introitus (compared to face) using a camera linked to a display screen by nulliparous women during self-motivated (non-directed) pushing for normal delivery as visual biofeedback will reduce birth-related injury (defined as major perineal injury or Caesarean delivery). |
| Ethics approval(s) |
Approved 14/08/2024, Medical Research Ethics Committee, University Malaya Medical Centre (Lembah Pantai, Kuala Lumpur, 59100, Malaysia; +60379493209/2251; ummc-mrec@ummc.edu.my), ref: 2024715-13916 |
| Health condition(s) or problem(s) studied | Self-motivated pushing for normal birth in the second stage of labour |
| Intervention | Patients admitted to the ward for planned vaginal delivery and who fulfil the study criteria after initial assessment will be approached for recruitment. A participant information sheet will be given to each potential recruit and their questions will be answered by the recruiting care provider. Informed written consent will be obtained from all participants. An instruction leaflet on the self-directed/motivated pushing technique will be distributed to each recruit. The randomisation sequence will be generated using an online random number generator in blocks of 4 or 8 by an investigator who is not involved in recruitment. Randomisation will be performed and the intention to treat revealed only at the decision to commence pushing. Randomisation is by opening the lowest number, sealed and opaque envelope still available for the latest recruit. Trial interventions are: 1. Visual biofeedback of maternal introitus (active) A video camera (e.g., a GoPro camera) will be placed on a stand at the end of the bed with the maternal introitus in focus and a display monitor (Bluetooth connected to the camera for live viewing) will be placed next to the bedside in clear view of the participant. Participants will then be allowed to push during labour on their own accord when motivated by contractions or need to bear down sensation. They will be instructed to employ any pushing technique that they are comfortable with and modify it based on feedback that they receive from the live-view display monitor. OR 2. Visual biofeedback of maternal face (control) A video camera (e.g., a GoPro camera) will be placed on a stand at the top of the bed with the maternal face in focus and a display monitor (Blue Tooth connected to the camera for live viewing) will be placed next to the bedside in clear view of the participant. Participants will then be allowed to push during labour on their own accord when motivated by contractions or need to bear down sensation. They will be instructed to employ any pushing technique that they are comfortable with and modify it based on feedback that they receive from the live-view display monitor. The live video feed streaming from the camera to the display monitor will not be recorded. The study interventions are complete at birth. |
| Intervention type | Mixed |
| Primary outcome measure | Major birth injury (second-degree or more severe perineal tear, or caesarean delivery) measured using data documented in the participant’s hospital chart after randomisation |
| Secondary outcome measures | 1. Duration of active second stage of labour measured using data documented in the participant’s hospital chart from the activation of biofeedback during active pushing to delivery (as contemporaneously recorded) 2. Maternal satisfaction with birth experience measured using scoring from 0 to 10 on a Numerical Rating Scale (NRS) before hospital discharge 3. Maternal outcomes measured using data retrieved from the patient’s electronic medical charts at hospital discharge: 3.1 Mode of delivery 3.2 Indication of operative delivery (operative vaginal and caesarean) 3.3 Estimated blood loss during delivery 3.4 Degree of perineal injury 4. Neonatal outcomes measured using data retrieved from the patient’s or offspring’s electronic medical charts at hospital discharge: 4.1 Birth weight 4.2 Umbilical cord arterial blood pH and base excess at birth 4.3 Apgar score at 1 and 5 minutes of life 4.4 Special care nursery/ neonatal intensive care unit admission during birth admission 4.5 Indication for neonatal admission 5. Major harms measured using data retrieved from the patient’s or offspring’s electronic medical charts at hospital discharge: 5.1 Hypoxic-ischaemic encephalopathy (neonatal) 5.2 Maternal admission to ICU for trauma sustained at birth |
| Overall study start date | 01/06/2023 |
| Completion date | 15/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 378 |
| Key inclusion criteria | 1. Age ≥ 18 years old 2. Nulliparous (no pregnancy after 20 weeks) 3. Singleton pregnancy 4. Cephalic presentation 5. No contraindication for vaginal delivery 6. Term ≥ 37 weeks 7. Reassuring fetal heart rate tracing 8. About to commence pushing for vaginal delivery |
| Key exclusion criteria | 1. Known major fetal anomaly 2. Planned instrumental delivery to shorten the second stage 3. Planned episiotomy 4. Maternal visual impairment (e.g., legally blind) 5. History of maladaptive maternal response to visual stimuli (e.g., migraine, seizure provoked) 6. Significant vulval-vaginal surgery |
| Date of first enrolment | 15/11/2024 |
| Date of final enrolment | 15/11/2025 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
University Malaya Medical Centre, Department of Obstetrics and Gynaecology, Faculty of Medicine, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 03-79492049 |
|---|---|
| ummc@ummc.edu.my | |
| Website | https://www.ummc.edu.my/ |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Research institutes and centers
- Alternative name(s)
- Faculty of Medicine - Universiti Malaya, Medicine Department - Faculty of Medicine - Universiti Malaya, medicineumalaya, University of Malaya Faculty of Medicine
- Location
- Malaysia
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| 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 | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
03/12/2024: Internal review.
21/10/2024: Study's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.
