RecruitingObservational

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

This study aims to see if midwives can accurately tell a baby's position in the womb, especially if it's breech (bottom down), using small, portable ultrasound machines. Currently, up to 40% of breech babies are missed with just feeling a mother's tummy. Knowing the baby's position is really important for planning a safe delivery, as breech babies can sometimes have a higher risk during birth. Researchers will compare the results from these small scanners with the more traditional hospital ultrasound scans. They also want to understand what pregnant women think about using these devices and if they could help the NHS reduce problems and save money. The study involves pregnant women between 35 and 37 weeks.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

9,648

Start

05 Aug 2024

Estimated completion

30 Nov 2026

Pregnant women

What is this study about?

Most babies settle head-down in the womb towards the end of pregnancy, but about 3 or 4 out of every 100 babies are breech, meaning they are bottom-down. Midwives usually check a baby's position by gently feeling the mother's stomach. However, this method can miss many breech babies. Knowing the baby's exact position is really important for making plans for a safe delivery, because breech babies can sometimes face higher risks during birth compared to head-down babies. If a breech baby isn't known about until birth, it can lead to problems for both the mother and the baby. This study is all about making sure women have the right information to make choices about their care.

The usual way to confirm a baby's position is with a standard ultrasound scan, which is done by specially trained staff using large machines in a hospital. Recently, smaller, handheld ultrasound devices have become available. These can connect to a mobile phone or tablet and are very portable. This study wants to find out if midwives can use these smaller machines to accurately determine a baby's position. They will compare the results from these handheld scanners with those from the traditional hospital ultrasound scans to see if they match.

Besides checking the accuracy of these new scanners, the research team also wants to hear what pregnant women and midwives think about using them. They will be asking questions and recording interviews. The study also wants to see if these small scanners could help prevent problems with undiagnosed breech babies, and if they could ultimately save money for the NHS. The team conducting this research includes many experts, like obstetricians (doctors who specialise in pregnancy and childbirth), midwives, ultrasound specialists, and economists, all working together.

Key takeaways

The study checks if midwives can use small ultrasound scanners to accurately find a baby's position.
This is important for planning safe births, especially if a baby is breech (bottom-down).
It compares new handheld scanners with standard hospital ultrasound machines.
Researchers also want to know what pregnant women think about these devices.
Taking part involves two ultrasound scans, usually within one day.
Ultrasound scans are very safe for both mother and baby.

Who may be eligible?

This study is looking for pregnant women to take part. You might be able to join if you are carrying one baby and are between 35 and 36 completed weeks of pregnancy (so, not quite 37 weeks yet). The study is taking place in various locations across the UK, including the North of England, the Midlands, the South Coast, London, and the East of England.

To be eligible, you need to be able to understand the study information and give your agreement to take part. You also need to be able to attend a second ultrasound scan within one day of the first scan. You won't be able to take part if you are expecting twins or more babies, or if you can't attend the second scan within the timeframe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant with one baby?
Are you between 35 weeks and 36 weeks and 6 days pregnant?
Can you understand the study information and agree to take part?
Can you attend a second ultrasound scan within one day of the first scan?
Are you able to travel to one of the participating maternity units in the UK?

Answer every question to see your result.

What does participation involve?

If you decide to take part, a midwife will invite you at your usual 36-week appointment. You will first have an ultrasound scan performed by a midwife using a small, handheld device. Afterwards, you will need to have another, standard ultrasound scan at the hospital. This second scan must happen within one day of the first scan with the handheld device, so it might mean an extra visit to the hospital for you. The study aims to compare the results of these two scans. Some women and midwives will also be asked to take part in recorded interviews to share their thoughts on using the handheld scanners. The study is expected to run from May 2023 until March 2027.

Potential risks and benefits

Both the handheld and standard hospital ultrasound scans are considered very safe and are not known to cause any harm to you or your baby. One potential inconvenience of taking part is that you might need to make an extra visit to the hospital for the second, comparison scan, depending on where and when your appointments are. There's a small chance your baby might change position after the scan; if this happens, your care team will discuss your options with you according to standard hospital guidance. You are always free to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (13)

Queen Charlotte's and Chelsea Hospital
City only
London, England
St Mary's Hospital
Approximate
London, England
Ipswich Hospital
Approximate
Ipswich, England
West Suffolk Hospital
City only
Lowestoft, England
East Surrey Hospital
Approximate
Redhill, England
Northwick Park Hospital
Unverified
Harrow, England
James Cook University Hospital
Unverified
Middlesbrough, England
United Lincolnshire Teaching Hospitals NHS Trust
Unverified
Lincoln, England
St Georges Hospital
Unverified
London, England
City Hospital NHS Trust
Unverified
Birmingham, England
Birmingham Women's and Children's NHS Foundation Trust
Unverified
Birmingham, England
Manchester University NHS Foundation Trust
Unverified
Manchester, England

Common questions

What is a 'breech baby'?

A breech baby is one positioned bottom-down or feet-down in the womb, instead of the usual head-down position, especially as you get close to your due date.

Why is it important to know if my baby is breech?

Knowing if your baby is breech is important for planning a safe delivery, as breech babies may come with different considerations for birth compared to head-down babies.

What is a 'handheld ultrasound'?

A handheld ultrasound is a small, portable device that connects to a phone or tablet. It's used to create images inside your body, similar to the bigger hospital ultrasound machines.

Will I get paid for taking part?

The information provided does not say whether participants will be paid. Clinical trials usually do not offer payment, but may cover travel costs.

Who is running this study?

This study is being run by a team of experts from several UK institutions, including Imperial College London and Cardiff University, and is funded by the NIHR (National Institute for Health and Care Research).

How to find out more

Eleri Owen-Jones

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

Always speak to your GP or specialist before deciding to take part in a study.