Every year, 800,000 women give birth in the UK, and nearly half of those pregnancies are now complicated by medical conditions that raise the risk of death or serious illness for mother and baby. This programme tackles three specific, unresolved problems in high-risk pregnancy care. For women with pre-eclampsia between 34 and 37 weeks, it asks whether immediate delivery is safer than waiting. For those with chronic hypertension, it tests which blood pressure drug works best and whether ethnicity changes the answer. For women with intrahepatic cholestasis of pregnancy, it asks whether a common bile-acid treatment actually reduces stillbirths and preterm births. The programme also aims to improve diagnostic tests for pre-eclampsia, which currently miss many high-risk women, and to evaluate a new NHS care pathway for hypertensive pregnancies. If successful, the research could directly reduce maternal organ damage, lower rates of preterm delivery and neonatal intensive care admissions, and give clinicians clear, evidence-based rules for when to deliver and which drugs to prescribe. The NHS would benefit from safer, more cost-effective management of a large and growing patient population.
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Background 800,000 women give birth every year in the UK. Medical co-morbidities now affect 45% of all pregnancies and greatly increase the risk of maternal and perinatal mortality and morbidity. This research programme focuses on high-risk pregnant women, aiming to reduce adverse outcomes for the mother and baby. The programme, funded principally by existing NIHR grants, comprises six work streams (WS) based at King's College London (KCL) and Guy's and St Thomas' NHS Foundation Trust (GSTT), and working within the national collaborative NIHR Clinical Research Networks. Hypertensive disorders of pregnancy (including pre-eclampsia and pre-existing chronic hypertension) and intrahepatic cholestasis of pregnancy (ICP) are associated with increased maternal and fetal morbidity and mortality in the UK and worldwide but uncertainties remain over management and treatment options. Aims To improve maternal and perinatal outcomes in high-risk pregnancies within five years this programme has the following aim: Aim 1 is to reduce maternal and perinatal mortality and morbidity through evidence-based interventions The following uncertainties have been identified as contributing to adverse maternal and perinatal outcomes and will be addressed (each through use of a multi-centre randomised controlled trial): In women with pre-eclampsia between 34+0 and 36+6 weeks' gestation, does delivery with minimal delay reduce maternal complications without short or long-term (neurodevelopmental) detriment to the infant, compared to expectant management? In pregnant women with chronic hypertension, which antihypertensive agent provides optimal blood pressure control and does ethnicity affect the efficacy of each drug class? In women with intrahepatic cholestasis of pregnancy, does ursodeoxycholic acid treatment reduce perinatal death, preterm delivery and neonatal unit admission? Aim 2 is to improve diagnostic and prognostic tests to enable increased stratified surveillance and improved management As current diagnostic tests perform poorly in women with suspected pre-eclampsia, and particularly in women with chronic hypertension and kidney disease, contributing to inadequate surveillance in those at highest risk of complication, the following studies will be undertaken to address these research questions: In women presenting with suspected pre-eclampsia before 37 weeks' gestation, does assessment incorporating PlGF measurement improve time to diagnosis, maternal and fetal outcomes and health resource use? (through a multi-centre stepped wedge design randomised controlled trial) In women with chronic hypertension and chronic kidney disease, is it possible to distinguish the phenotypes of super-imposed pre-eclampsia and pregnancy associated kidney injury in order to improve clinical decision-making and reduce iatrogenic preterm delivery? (through a prospective longitudinal cohort study) Aim 3 is to evaluate the implementation of evidence into clinical practice through new service delivery models Implementation of a new service delivery model and care pathway for women with hypertension in pregnancy will be evaluated through investigation of barriers and facilitators with robust measurement of clinically relevant processes and outcomes in order to inform dissemination of best practice for implementation of such a service on a wider level, regionally and nationally. Aim 4 is to build research capacity, inspiring and nurturing the next generation of multidisciplinary researchers in this field Potential benefits to patients and the NHS The personal, family, societal and economic costs of adverse outcomes in high-risk pregnancies are immense. This programme seeks to undertake rigorous high-quality research within the NHS designed to address the uncertainties identified, and evaluate implementation of a new service delivery model for these women, in order to have a direct, measurable impact on improving health of pregnant women and babies within a five-year timescale. The benefits will be to the women (through reduction of multi-organ complications), to their babies (through lower short- and long-term morbidity), to the health service (by safe, cost-effective management) and to society through improved health and wealth of this important population.
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