Researchers are set to test a revolutionary screening method for pre-eclampsia, a serious condition that can affect both pregnant women and their babies. This groundbreaking study, named the Screen and Treat with Aspirin to Reduce Pre-eclampsia (STARshiP) trial, is being led by Saint Mary’s Managed Clinical Service, part of Manchester University NHS Foundation Trust (MFT), in partnership with The University of Manchester and the Nottingham Clinical Trials Unit at the University of Nottingham.
The STARshiP trial, involving 200,000 women and their babies, is one of the largest studies in pregnancy screening research to date. Funded by the National Institute for Health and Care Research (NIHR) and sponsored by The University of Manchester, the trial aims to revolutionize how pre-eclampsia is managed during pregnancy.
Pre-eclampsia typically occurs during the second half of pregnancy, starting from around 20 weeks, or shortly after childbirth. Early symptoms include high blood pressure and protein in the urine. While the condition affects up to 8% of pregnancies, predicting which women are at risk remains challenging.
The STARshiP study aims to improve early detection of women at high risk for pre-eclampsia and provide aspirin as a preventative treatment. The new screening will be offered alongside the early pregnancy scan and will evaluate the benefits of this approach.
Key aspects of the STARshiP study include:
Combined Screening Technique: This new method uses additional measurements from the first-trimester ultrasound scan and a blood test to assess placental hormones.
Aspirin Treatment: Women identified as high-risk through the new screening will receive aspirin, a proven, safe, and cost-effective treatment that can reduce the severity and incidence of pre-eclampsia.
Efficient Trial Design: The trial, known as a ‘stepped wedge clinical trial,’ will gradually implement the screening test across participating maternity hospitals. This design allows all participating hospitals to eventually use the test by the end of the study.
The STARshiP trial will be conducted at 18 maternity hospitals in the North of England and the East Midlands, including Saint Mary’s Hospital, North Manchester General Hospital, and Wythenshawe Hospital.
Professor Jenny Myers and Dr. Lucy Higgins from The University of Manchester are leading the trial. Professor Myers, Clinical Professor and Consultant Obstetrician at Saint Mary’s Hospital, commented, “This trial has significant potential to show the benefits of a more effective screening test for pre-eclampsia and reduce the impact of this severe pregnancy complication.”
Dr. Higgins, Senior Clinical Lecturer and Honorary Consultant Obstetrician, added, “By enhancing early screening, we hope to lower the risks associated with pre-eclampsia and improve outcomes for both mothers and babies.”
Dr. Jane Harvey, from the Patient and Public Involvement Group (PPI), shared her personal experience: “I was unaware I was at risk of pre-eclampsia, and when it occurred, it was terrifying. It’s wonderful that this new test could help prevent this life-changing condition for many families.”
Jane Daniels, Professor of Clinical Trials at the Nottingham Clinical Trials Unit, expressed excitement about the study: “We are thrilled to coordinate this large screening trial. Although these studies take time, we hope the results will provide the best methods for identifying at-risk pregnancies and making them available to everyone.”
