Researchers are to trial a ground-breaking screening test for pre-eclampsia, a potentially life-threatening condition affecting pregnant women and their unborn babies.
The Screen and Treat with Aspirin to Reduce Pre-eclampsia (STARshiP) study is led by researchers from Saint Mary's Managed Clinical Service, part of Manchester University NHS Foundation Trust (MFT), in collaboration with The University of Manchester and the Nottingham Clinical Trials Unit at the University of Nottingham.
With the study of 200,000 women and their babies, STARshiP represents one of the largest endeavours in pregnancy screening research.
Funded by the National Institute for Health and Care Research (NIHR) and sponsored by The University of Manchester, the trial aims to transform antenatal care of the condition.
Pre-eclampsia is a condition that affects some pregnant women, usually during the second half of pregnancy (from 20 weeks) or soon after their baby is delivered.
Early signs of pre-eclampsia include having high blood pressure and protein in the urine.
Though the condition occurs in up to 8% of pregnancies, there are currently few ways to predict which patients may be at risk.
With the aim of improving the detection of women at higher risk of developing the condition and offering aspirin as a preventative treatment, the STARshiP study will quantify the benefit of the screening, offered by the researchers at the same time as the early pregnancy scan.
Key features of the STARshiP study include:
- Combined Screening Technique using the Fetal Medicine Foundation Test: The STARshiP study will implement a new screening method for pre-eclampsia which includes additional measurements taken during the first trimester ultrasound scan and a blood test to measure placental hormones.
- Aspirin Treatment to reduce the risk of pre-eclampsia: Pregnant people identified as high-risk through the new screening process will receive aspirin treatment as per the current NHS standard care. Aspirin is a safe, cost-effective treatment which has been shown to reduce the incidence and severity of pre-eclampsia.
- Efficient Trial Design: The STARshiP study is designed in a way that the screening test will be rolled-out across participating maternity hospitals, with all participating hospitals having implemented the screening test by the end of the study. This type of research study is called a 'stepped wedge clinical trial' and is an efficient way of conducting a clinical trial, resulting in everyone having the opportunity to try implementing the test during the study.
The STARshiP study will span across 18 maternity hospitals in the North of England and East Midlands regions. At MFT it will be rolled out by Saint Mary's Managed Clinical Service (MCS), across its three sites: Saint Mary's Hospital, North Manchester General Hospital and Wythenshawe Hospital.
Professor Jenny Myers and Dr Lucy Higgins are joint chief investigator of the STARshiP trial.
Professor Myers, Clinical Professor at The University of Manchester and Consultant Obstetrician, Maternal and Fetal Health Research Centre, Saint Mary's Hospital, said: "The immense promise this trial has in demonstrating the impact of a more effective screening test for pre-eclampsia and reducing the burden of this devastating pregnancy complication is more relevant than ever."
Dr Higgins, Senior Clinical Lecturer at The University of Manchester and Honorary Consultant Obstetrician, Maternal and Fetal Health Research Centre, Saint Mary's Hospital, said: "By integrating improved early screening, we aspire to mitigate the risks associated with this condition and improve maternal and fetal outcomes."
Marcus Green, CEO of Action for Pre-eclampsia (APEC) said: "Women need to know if they are at risk of pre-eclampsia both so they can be prepared and to ensure clinicians target the right care to them. This study will hopefully help find one more piece in the pre-eclampsia jigsaw and we will be fully supporting the trial."
Dr Jane Harvey, a representative from the Patient and Public Involvement Group (PPI) said: "I never thought I was at risk of pre-eclampsia, when it happened it was terrifying. It is absolutely fantastic that this new test could potentially prevent this life-changing disease from affecting the lives of so many families."
Jane Daniels, Professor of Clinical Trials at the Nottingham Clinical Trials Unit at the University of Nottingham, said: "NCTU are excited to be coordinating another large screening study in pregnancy. Although these studies take time, we hope that the results will ensure the best method of identifying at-risk pregnancies, is available for everyone."
