Oxford Placental Ultrasound OxPLUS Study
The aim of this study is to establish if a new piece of computer software, called the ‘OxNNet toolkit’ can predict which babies will not grow as well as they should using the information gained from the 3D ultrasound scan about the size of the placenta and its blood flow, together with other known risk factors.
ABOUT THE STUDY
The placenta (sometimes called the ‘afterbirth’) works as the baby’s ‘life-support system’ enabling them to grow to their full potential. Unfortunately, sometimes the placenta does not work as well as it needs to. When this happens, the baby does not grow as well as it should, which can lead to problems and sometimes, even to the loss of the baby. This study aims to see if a new piece of computer software, called the ‘OxNNet toolkit’ can predict which babies will not grow as well as they should using the information gained from the 3D ultrasound scan about the size of the placenta and its blood flow, together with other known risk factors. This may be used in the future as a screening test for all pregnancies, to identify when the baby may be at risk. This will allow issues to be identified much earlier so that babies at risk of not growing properly can be monitored more closely.
WHO CAN PARTICIPATE IN THIS STUDY?
Pregnant women aged 18 years or above who are in the first few months of pregnancy and attending their routine 11-14-week (‘first trimester’) ultrasound scan at the John Radcliffe Hospital, Women’s Centre, Oxford.
WHAT TO EXPECT
If you would like to take part, you will have an extra 3D ultrasound scan to take pictures of your placenta. This will take place during your routine first trimester scan. A small amount of blood from your routine blood sample will also be used to run a test called placental growth factor (PlGF).
You will also be asked some questions about your pregnancy and we will look up your pregnancy records after you deliver to confirm the outcome of your pregnancy.
The steps below describe what to expect if you agree to participate in this research and are anticipated to add approximately 10 minutes to your routine appointment time.
Eligibility Check and Consent Process
During your appointment, you will be asked if you would like to undergo first trimester combined screening as part of your routine first trimester pregnancy scan. The combined screening test is an optional addition to the usual ‘dating’ scan and involves taking a blood sample to analyse for potential genetic abnormalities such as Down’s syndrome. If you choose to undergo this screening, you will be eligible to take part in the OxPLUS study.
If you would like to take part, you will be provided with a participant information leaflet and given time to read and ask questions if you have any. You will then be asked to sign a consent form to confirm your participation. The OxPLUS study only involves one ultrasound scan which will be done at the same time as your routine first trimester ultrasound scan. No other visits will be required and the researchers will follow up the outcome of your pregnancy from your notes after you deliver.
We will ask a few questions regarding your medical history for example if you have high blood pressure (BP) or diabetes.
We will record your BP in both arms, a carbon monoxide reading and your height and weight.
The 3D ultrasound scan will take place immediately after your routine scan and will take an additional 3-4 minutes. This extra scan is only of your placenta not your baby and will not be used for any clinical purpose.
You will have a blood sample taken as part of your routine care. We will use some of the blood left over from your sample to run an extra test for Placental Growth Factor (PlGF). The result of the PIGF test is one way doctors can try and predict if a baby will not grow as well as it should.
After you have birthed your baby, the research team will access your pregnancy records to collect information about any hospital appointments you have had during your pregnancy and to find out the outcome of your pregnancy. Please note, this does not require you to attend for any further appointments
HOW CAN I GET INVOLVED?
When you arrive for your first trimester scan, a researcher will approach you and ask whether you would like to participate. If you have any questions about this you can contact Dr Sam Mathewlynn on 07955 434639 or email firstname.lastname@example.org
This study has been ethically approved by the North West - Greater Manchester Central Research Ethics Committee
REC number: 23/NW/0035
Accredited practitioners of first trimester 3D placental ultrasound
The following practitioners are certified as competent in the technique of first trimester 3D placental ultrasonography:
Sadeghi Kaji, Shila