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Live camera viewing by the first-time mother of the birth canal opening as a feedback aid during self-motivated pushing for normal delivery

Live visual biofeedback of maternal introitus vs maternal face during self-motivated pushing in nulliparas: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94920608
Enrollment
378
Registered
2024-10-21
Start date
2024-11-15
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-motivated pushing for normal birth in the second stage of labour Pregnancy and Childbirth

Interventions

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

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Malaysia

Contacts

Public ContactProf. Dr. Tan Peng Chiong
tanpengchiong@yahoo.com+60 03-79492049

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026