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

Research question: What is the diagnostic accuracy of point of care ultrasound (PoCUS) for detecting breech presentation at term? Population: Women with singleton live pregnancy at 35-37 weeks of gestation. Intervention: Hand-held PoCUS for fetal presentation undertaken by midwives

Comparator: Examination for fetal presentation conducted by a sonographer using conventional ultrasound equipment on the same women and on the same day as the hand-held PoCUS. Outcome: Accuracy of PoCUS & clinical abdominal palpation for detection of breech presentation at term.

Background: While over 95% of babies at term are cephalic presentation, 3-4% are breech and of these 30-40% are missed at routine antenatal checks that rely on midwives using their hands (abdominal palpation). Hence 1% of women in labour have babies that are unexpectedly breech, allowing little time for informed choice about the safest way for baby to be delivered. A sudden change in birth expectations is associated with postnatal post-traumatic stress disorder for women and birth partners.

Aims:

1) To assess the accuracy of midwives detecting breech presentation using a hand-held PoCUS compared to conventional sonographer ultrasound 2) To assess acceptability of the hand-held PoCUS with midwives & pregnant women 3) To evaluate the cost effectiveness of midwives using hand-held PoCUS 4) To evaluate the training needs of midwives undertaking hand-held PoCUS through surveys and questionnaires

5) To explore if undetected breech presentation in labour will be reduced with routine use of PoCUS

Primary Outcome: Diagnostic accuracy (sensitivity & specificity) of midwife conducted hand-held PoCUS for detection of breech presentation at term compared to ‘gold standard’ conventional ultrasound.

Secondary outcomes: (a) acceptability to midwives and pregnant women of hand-held PoCUS (b) resource use including mode of birth and neonatal intensive care unit (NICU) admission and length of stay obtained from patient records (c) evaluation of training requirements for midwives using hand-held PoCUS (d) Proportion of breech presentations that remain undiagnosed in labour (e) change in management (f) positive pregnancy outcome (g) Infant Quality of Life Instrument (IQI).

Secondary outcomes b, f & g form the cost-effectiveness analysis. Methods:

Multicentre observational study in 10 maternity units. At 36 week hospital or community antenatal visit, eligible participants will be identified by the midwife & following consent abdominal palpation to determine fetal presentation and hand-held PoCUS are undertaken. Same-day conventional ultrasound for fetal presentation with a sonographer is offered in a dedicated clinic.

Timelines for delivery: Initial 6 months: regulatory steps & team training Active recruitment: 18 months Post recruitment: 2 months collection & validation of data; analysis in last 4 months. Anticipated impact and dissemination:

Step 1: Participant facing, targeting service users & staff across all sites to ensure inclusivity and transparency. Dissemination of plain English progress reports via newsletter emailed to those involved & informatic summaries displayed across the participating Trusts on staff and service user notice boards.

Step 2: Focus on wider dissemination of the research beyond study centres with dedicated study website, Twitter & Instagram feeds. Step 3: Clinical and academic conference presentations & submissions to high impact clinical journals.