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Imaging of the birth canal opening during labour as a pushing aid among first-time mothers

Real-time imaging as visual biofeedback in active second stage of labour among nulliparas women: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57404917
Enrollment
220
Registered
2021-11-23
Start date
2021-12-01
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Childbirth Pregnancy and Childbirth

Interventions

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 a

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Measured using patient records at the end of the study: 1. Duration of the active second stage of labour which defined as the minutes from the start of biofeedback during active pushing to delivery of fetus 2. Maternal satisfaction with pushing experience during birth

Secondary

MeasureTime frame
Measured using patient records at the end of the study: 1. Birth weight (kg) 2. Umbilical cord arterial blood pH and base excess at birth 3. Health at birth measured using Apgar score at 1 and 5 minute 4. Special care nursery/ neonatal intensive care unit admission during birth admission 5. Indication for neonatal admission 6. Mode of delivery 7. Estimated blood loss during delivery 8. Degree of perineal tear

Countries

Malaysia

Outcome results

None listed

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