Pre-eclampsia Pregnancy and Childbirth
Conditions
Interventions
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), materna
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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 Moreover, the draft guidance from the NSC has not recommended the implementation of universal screening.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 strategies. The window for FMF testing is 11+2 to 14+1 weeks (crown-rump length 45-84mm). Eligibility is not dependent on participation in the NHS Fetal Anomaly trisomy screening programme INCLUSION CRITERIA – DATASET LEVEL 1. All pregnant women/people receiving antenatal care at participating maternity units within randomised NHS Trusts prior to 16 weeks gestation. Individuals may be included more than once if multiple early pregnancy screening episodes in different pregnancies are performed. 2. Women/people who experience a miscarriage or stillbirth after early pregnancy screening will be included as they may have had testing for PE and PE may be implicated in the aetiology of their pregnancy loss. INCLUSION CRITERIA FOR THE QUALITATIVE STUDY: QUESTIONNAIRES Professionals who: 1. Are working in an NHS Trust taking part in the study 7 weeks after the FMF screening has been implemented at the site (clinical and non-clinical staff). 2. Have the ability to complete an online questionnaire through access to a URL or QR code. 3. Have completed the declaration of consent to participate in the questionnaire. Women/people who: 1. Have commenced maternity care in a participating NHS Trust during the study period. 2. Have the ability to complete an online questionnaire through access to a URL or QR code. 3. Have completed the declaration of consent to participate in the questionnaire. 4. Women/people who were unable or unwilling to undergo PE screening will not be excluded. IN
Exclusion criteria
Exclusion criteria: 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 experienced in one of the participating NHS Trusts taking part in the study. Those who were unable to unwilling to undergo PE screening will not be excluded. 4. Who are less than 6 weeks, or more than 6 months postnatal at the time of interview. Professionals who: 1. Have not completed the online questionnaire or who decline consent to contact for the interview study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Iatrogenic (through inducing labour or by caesarean) preterm (<37 weeks of pregnancy) birth rates (including stillbirths) measured using data extracted from the national routinely collected healthcare system data at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are measured using data routinely collected healthcare system data at one time point: Maternal: 1. Mortality 2. Postpartum haemorrhage 3. Labour onset 4. Mode of birth 5. Caesarean section indication (Robson Group) 6. Blood transfusion 7. Admission to intensive/high-dependency care 8. Length of stay (postpartum) 9. Length of stay (cumulative per pregnancy) 10. Readmission to hospital (within 42 days) Neonatal: 1. Stillbirth (death of a baby after 24 completed weeks; occurring before or during birth or timing unknown) 2. Gestational age at birth 3. Small for gestational age neonate (<10th centile for GA) 4. Fetal growth restriction (<3rd centile for GA or <10th centile if born under 34 weeks) 5. Birth weight (grams) 6. Early neonatal mortality (<7 days of age) 7. Extended neonatal mortality (<28 days of age) 8. Admission to neonatal unit 9. Level of neonatal care (level 1, 2 or 3) 10. Length of hospital stay (days) 11. Readmission to hospital (within 42 days) 12. Respiratory morbidity (as recorded): 12.1. Respiratory distress syndrome 12.2. mechanical ventilation 12.3. chronic lung disease 12.4. discharge on oxygen 13. Neurological morbidity (as recorded): 13.1. Seizures 13.2. Hypoxic ischaemic encephalopathy 13.3. Therapeutic hypothermia 13.4. Retinopathy of prematurity 13.5. Hearing impairment 14. Gastrointestinal morbidity: 14.1. Necrotising enterocolitis 14.2. Laparotomy Process outcomes (collected for the study): 1. Number of pregnant women/people with clinical risk factors for PE and which risk factors they have. 2. Number of pregnant women/people having a blood test taken for PIGF (of all those eligible for this test). 3. Number of pregnant women/people having an ultrasound scan for UtA-PI (of all those eligible for this test). 4. Number of pregnant women/people with a PIGF result of all those having the test taken. 5. Number of pregnant women/people having a blood test for the FMF screening test within the time | — |
Countries
England, United Kingdom
Contacts
Public ContactKousthubha Janaki Ramaiah
Outcome results
None listed