What is the diagnostic accuracy of midwife-delivered point-of-care ultrasound for detecting breech presentation at term?

Diagnostic accuracy of handheld ultrasound at 36 weeks of gestation to determine fetal presentation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11748052

Enrollment

9648

Registered

2025-04-30

Start date

2024-08-05

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Pregnant women Pregnancy and Childbirth

Interventions

There are three components to the study: the main diagnostic accuracy study

a nested acceptability study using qualitative methodology

and a health economic evaluation to evaluate cost-effectiveness. 36-week appointment: At routine 36-week antenatal appointments, eligible pregnant women will be consented to take part in the Sono-bre

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Singleton live pregnancy 2. 35+0 - 36+6 weeks of gestational age 3. Ability to give valid informed consent 4. Commitment to attend a second scan within 1 day 5. Midwifery sample eligibility – being part of the Sono-breech study and undertaking PoCUS scanning as part of this study

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Unable to attend a second scan within 1 day

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy (sensitivity and specificity) of midwife-conducted handheld PoCUS at 36 weeks for the detection of breech presentation compared in the same women to ‘gold standard’ conventional ultrasound	—

Secondary

Measure	Time frame
1. Acceptability to midwives and pregnant women of handheld PoCUS in the detection of breech presentation at term, measured using focus groups (midwives) during the study period; and interviews (pregnant women) up to 12 weeks after birth 2. Resource use including mode of birth and neonatal intensive care unit (NICU) – reasons and outcome of admissions, and length of stay obtained from patient records for up to 28 days 3. Evaluation of training requirements for midwives using handheld PoCUS for fetal presentation, measured using focus groups during the study period 4. Proportion of breech presentations that remain undiagnosed in labour and resulting change in management, measured using a Pregnancy Outcome CRF recorded up to 12 weeks after birth 5. Birth experience measured using the Birth Experience Assessment Measure completed up to 6 weeks after birth 6. Infant quality of life measured using the Infant Quality of Life Instrument (IQI) completed up to 6 weeks after birth	—

Measure

Time frame

1. Acceptability to midwives and pregnant women of handheld PoCUS in the detection of breech presentation at term, measured using focus groups (midwives) during the study period; and interviews (pregnant women) up to 12 weeks after birth 2. Resource use including mode of birth and neonatal intensive care unit (NICU) – reasons and outcome of admissions, and length of stay obtained from patient records for up to 28 days 3. Evaluation of training requirements for midwives using handheld PoCUS for fetal presentation, measured using focus groups during the study period 4. Proportion of breech presentations that remain undiagnosed in labour and resulting change in management, measured using a Pregnancy Outcome CRF recorded up to 12 weeks after birth 5. Birth experience measured using the Birth Experience Assessment Measure completed up to 6 weeks after birth 6. Infant quality of life measured using the Infant Quality of Life Instrument (IQI) completed up to 6 weeks after birth

—

Countries

England, United Kingdom

Contacts

Public ContactEleri Owen-Jones

owen-jonesce@cardiff.ac.uk+44 (0)29 2068 7620

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026