Oxford Placental UltraSound (OxPLUS) Study V1.0
Research type
Research Study
Full title
Oxford Placental UltraSound (OxPLUS) Study: an observational cohort study to assess the clinical utility of the OxNNet Toolkit for the prediction of adverse pregnancy outcomes
IRAS ID
322242
Contact name
Sally Collins
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
The OxPLUS study is a prospective, observational, cohort study, which will recruit 3500 women from the John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust which provides ultrasound scanning for all women who attend the Women's Centre for their pregnancy care. This study aims to develop a tool to provide reliable measurements of placental size and estimate the blood flow within the placenta during the first trimester of pregnancy. These metrics hope to develop a screening tool for fetal growth restriction (FGR), which is a condition in which a baby fails to grow to its full potential and can cause adverse pregnancy outcomes and is the single most common cause of stillbirth. This devastating outcome could potentially be reduced by stratifying pregnancies into high risk, allowing women to undergo additional monitoring and limiting clinician resource to those in need of it most. Stillbirth is also a serious adverse pregnancy outcome that NHS England is looking to reduce the rate of as part of their long-term plan.
Women 18 years of age or older, attending their first trimester scan during 11-14 weeks of pregnancy, who have a viable pregnancy with no more than one baby with no major defects identified during the scan will be eligible to take part.
The study will take place over 18 months and participants will undergo a single study visit in which their pertinent medical history, blood pressure, carbon monoxide reading, height and weight will be recorded. An additional research ultrasound scan will be conducted alongside their routine scan and residual blood from a sample taken as part of routine care will be used to assess the level of Placental Growth Factor (PlGF). Participants will be followed up until the completion of their pregnancy via their pregnancy records (remote follow up) and the outcome of their pregnancy recorded.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0035
Date of REC Opinion
20 Feb 2023
REC opinion
Further Information Favourable Opinion