STARshiP: Screen and Treat with Aspirin to Reduce Pre-eclampsia
Pre-eclampsia
Intervention: FMF screening test for pre-eclampsia risk in the first trimester. This algorithm involves a uterine artery Doppler ultrasound measurement (UtI-PI), a blood test (measuring PlGF), maternal blood pressure and maternal risk factors. Control (Usual care): NHS Trusts will follow the NICE risk factor-based screening approach to identify those at high risk of preeclampsia.
INCLUSION CRITERIA FOR THE MAIN STEPPED WEDGE RANDOMISED CONTROLLED STUDY: There are eligibility criteria at a trust level, which determine which maternity units can participate; at a testing level for women and people giving birth in testing maternity units; and at a dataset level. INCLUSION CRITERIA - TRUST LEVEL: 1. Located in England. 2. Have a minimum of 2500 births per year (latest full-year data) in the participating National Health Service (NHS) Trust. 3. NHS Trusts with fewer than 2500 births per year may potentially be paired together to create a randomisation unit for the purpose of the study. 4. Committed to universal implementation of the Fetal Medicine Foundation (FMF) screening test within a specified time point following study commencement. NHS Trusts that have more than one maternity unit will be randomised as a Trust to preserve fidelity of implementation across all maternity units within a Trust. NHS Trusts with fewer than 2500 births per year may potentially be paired together to create a site for the purpose of the trial. This option will only be pursued if insufficient NHS Trusts are eligible and can commit to STARshiP in a timely manner Whilst it is possible that maternity units will choose to implement the test outside of our study, this decision would make them ineligible for participation. Importantly, it would also mean that the financial and training resources embedded within our trial design would not be available. Moreover, the draft guidance from the NSC has not recommended the implementation of universal screening. INCLUSION CRITERIA - INDIVIDUAL LEVEL: There will be two levels of eligibility for individual women/birthing people, these are testing-level eligibility and dataset-level eligibility. TESTING LEVEL INCLUSION CRITERIA: All pregnant women/people receiving antenatal care at participating maternity units within randomised NHS Trusts prior to 16 weeks gestation will be eligible to be screened by either the NICE or FMF
EXCLUSION CRITERIA - TRUST LEVEL: 1. NHS Trusts will be ineligible to participate in the study if they are: 1.1. Already providing first-trimester screening for pre-eclampsia (PE) as standard care, or participating in another study implementing care pathways which include first-trimester screening for PE 1.2. Unable to commit to the implementation of the FMF screening test at the specified time point. Trusts may still participate where they are able to make a commitment to performing all elements of the FMF screening test where feasible. Trusts would be unable to participate if they are absolute in the knowledge that they would not be possible to perform any UtA-PI measurements following the specified transition time point EXCLUSION CRITERIA - INDIVIDUAL LEVEL There will be two levels of eligibility (and thus exclusion) for individual women/birthing people, these are testing level eligibility and dataset level eligibility. TESTING LEVEL EXCLUSION CRITERIA: 1. Known congenital anomaly incompatible with survival at birth, of a singleton or all multiple fetuses e.g. anencephaly. 2. Fetal demise/miscarriage before PE risk assessment completed. DATASET LEVEL EXCLUSION CRITERIA: 1. Withdrawal of consent to use data, through either the local study-specific opt-out process or the NHS data-opt-out. 2. Pregnancy outcome data for those screened during the transition phase for each maternity unit will be collected but excluded from the primary outcome analysis; it will be available for use in secondary analyses. EXCLUSION CRITERIA FOR THE QUALITATIVE STUDY: QUESTIONNAIRES Women/people who: 1. Lack of capacity to give informed consent. 2. Those who were unable or unwilling to undergo PE screening will not be excluded. 3. Are more than 6 months postnatal at the time of questionnaire entry. INTERVIEWS Women/people who: 1. Have not completed the online questionnaire or who decline consent to contact for the interview. 2. Lack of capacity to give informed consent. 3. Have not