Around 190,000 pregnant women across 18 NHS maternity units will be screened for pre-eclampsia risk using a new test that combines an ultrasound scan, a blood test, and blood pressure measurements, to see if it cuts the number of medically induced preterm births. Current NHS guidelines rely on checking risk factors like age and medical history, which misses many at-risk women, particularly those from Black and minority ethnic backgrounds. The new Fetal Medicine Foundation test identifies twice as many high-risk pregnancies, allowing earlier treatment with low-dose aspirin to prevent the condition. Pre-eclampsia is a dangerous blood pressure disorder that can force doctors to deliver babies early to save the mother’s life. If the trial shows the new screening reduces preterm births, it could change national screening policy across the UK. The study also includes a cost-effectiveness analysis and interviews with patients and staff to assess whether the test is practical and acceptable in routine care. Results will directly inform decisions by NICE and the UK National Screening Committee on whether to adopt the test nationwide.
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RESEARCH QUESTION In the first trimester of pregnancy, does universal implementation of the Fetal Medicine Foundation (FMF) screening test for pre-eclampsia (PE) compared to National Institute for Health and Care Excellence (NICE) guidelines reduce (iatrogenic) preterm birth (PTB)? BACKGROUND Low dose aspirin (LDA) started <16 weeks’ gestation reduces the incidence of PE and PTB in higher risk pregnancies. Current risk factor-based screening performs poorly in nulliparous and Black and Minority ethnic populations. A new screening test combining maternal characteristics with an ultrasound scan and blood test doubles the identification of pregnancies at greatest risk of PE but its clinical/cost-effectiveness at reducing (iatrogenic) PTB is unclear. AIMS 1. To determine whether (universal) implementation of the FMF screening test for PE reduces (iatrogenic) PTB 2. To assess the cost effectiveness of the FMF screening test for PE in the whole population and in pre-specified subgroups 3. To assess acceptability and identify barriers and facilitators of routine adoption of the FMF screening test 4. To assess the impact on experience of FMF screening test implementation on healthcare professionals, women/birthing people and service providers METHODS Design: Stepped wedged, cluster randomised trial with parallel economic and implementation evaluation. Population: pregnant women/birthing people in the first trimester of pregnancy. Setting: 18 maternity units in the Midlands and North of England. Each unit will be randomised to implement the new screening test at a specific changeover date. Intervention: The FMF screening test, an algorithm involving uterine artery Doppler ultrasound measures, PlGF blood test, maternal blood pressure and risk factors. Comparator: usual care by identification of maternal risk factors alone (according to NICE guidelines). All women/birthing people identified as at higher risk of PE will be prescribed LDA prophylaxis. Outcomes: Primary: (iatrogenic) preterm rate (including stillbirths). Secondary: adapted from PE, PTB and neonatal care core outcome sets. The majority of data will be obtained from national routine sources, with only screening test data collected individually within maternity units. Size and design: We assume an average of 4,500 births per unit/year, 3.5 month block length, three units switching per block and six changeover timepoints. All units start in a usual care block, followed by an implementation phase (not contributing data) according to randomised changeover date, before beginning the intervention phase. The total number of pregnancies included in the analysis will be ~190,000, providing 86% power to detect a 0.4% absolute risk reduction in the iatrogenic PTB rate. Economic evaluation: within-trial analysis of cost per (iatrogenic) PTB avoided and a decision model of cost per quality-adjusted life year. Implementation analysis: mixed-methods analysis of service user/professionals surveys and interviews, assessing acceptability of, and barriers/facilitators to, PE screening and its impact on service user experience/service provision. IMPACT AND DISSEMINATION Study results will be disseminated widely to health professionals, policy-makers, charities/support groups and pregnant women/birthing people and parents. Our parent/public partners will help inform our dissemination strategy. NICE and the National Screening Committee will use our results to decide national policy.
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