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21/582 Point of care ultrasound for breech presentation at term commissioning brief

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

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

  1. Technologies: Midwife conducted abdominal palpation plus midwife conducted point of care (POCUS)/handheld ultrasound.
  2. Target group: Pregnant women in the late third trimester (applicants to define and justify). Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field and should include all people eligible for recruitment.
  3. Setting: Routine midwife antenatal appointments.
  4. Reference standard: Sonographer conducted ultrasound, or equivalent (applicants to define and justify).
  5. Study design: Diagnostic accuracy study.
  6. Important outcomes: Sensitivity and specificity; positive and negative predictive value; maternal and infant morbidity; acceptability (patient and healthcare provider).
  7. Other outcomes: Need for external cephalic version; type of birth; Manualisation of any training requirements for midwives to become competent in the performance and interpretation of POCUS; measures of fidelity; acceptability and willingness to change practice; healthcare resource use. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.

Rationale

Breech presentations, where the unborn baby lies buttocks, rather than head-down (cephalic presentation) in the uterus, complicate approximately 3-4% of births and are associated with higher perinatal mortality and morbidity when compared to cephalic presentations.

While vaginal birth of a breech baby is possible it is often not recommended for a variety of reasons and instead a caesarean section would be planned. If detected at the appropriate time (around 36 weeks) it can be possible to turn the baby into the preferred cephalic position with an external cephalic version (ECV), a non-invasive and safe procedure involving manual manipulation of the baby inside the abdomen.

Current routine practice to determine presentation is by manual palpation (feeling the position of the baby in the bump using the hands) and is usually conducted by a midwife during a routine antenatal appointment. Palpation screen positive women would usually be referred for confirmatory ultrasound and subsequent discussions about ECV and breech birth implications.

Previous evidence suggests however that up to 40% of breech presentations might be missed by palpation. Only if there were additional concerns or risk factors would palpation screen negative women be referred for ultrasound where breech might then be detected and ECV etc then be possible.

A recent review of the available evidence commissioned by the NIHR HTA programme suggested that routine ultrasound in late pregnancy (around 36 weeks) could potentially help to identify the significant majority of breech presentations, and therefore might have an impact on perinatal outcomes. If conducted by midwives, the study estimated that routine point of care ultrasound would be effective and cost-effective.

Uncertainty remains however specifically around the diagnostic accuracy of midwife delivered point of care ultrasound to determine breech presentation, which would be used as an adjunct to abdominal palpation, and how closely this corresponds to sonographer confirmed detection.

If it can be demonstrated that midwives can effectively and cost-effectively be trained and then conduct ultrasound scans to detect breech presentation with high sensitivity and specificity and this makes a material difference to subsequent maternal and/or neonatal outcomes there would be a strong case for introduction of such practice into routine care.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 30 March 2022. Applications will be considered by the HTA Funding Committee at its meeting in May 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk