Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Multi-centre RCT of revealed versus concealed repeat PlGF-based testing in women presenting with suspected pre-eclampsia between 22+0 and 35+6 weeks’ gestation. The trial will be conducted in at least
from previous studies it is anticipated that most women will provide two samples as the majority of women will be delivered within that time interval.
For both the revealed repeat testing and conceal
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years or more between 22+0 and 35+6 weeks’ gestation with clinical suspicion of pre-eclampsia 2. Viable singleton pregnancy 3. Able to give written informed consent
Exclusion criteria
Exclusion criteria: Confirmed preterm pre-eclampsia at presentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of: 1. Stillbirth defined as death of a fetus after 24 weeks' gestation and before birth collected by 6 weeks post birth 2. Early neonatal death defined as death occurring within the first 7 days of life collected by 6 weeks post birth 3. Neonatal unit admission defined as admission of the neonate to the neonatal unit and captured within the first 6 weeks from birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional fetal and neonatal outcomes: 1. Late neonatal death defined as neonatal death occurring between 7 and 28 days after birth and captured from hospital records by 6 weeks post birth 2. Need for respiratory support on Neonatal Unit defined as the need for CPAP/high flow/endotracheal ventilation and recorded by 6 weeks post birth 3. Gestational age at delivery measured in days and recorded by 6 weeks post birth 4. Birthweight centile <10th calculated using recorded birth weight and using the Intergrowth 21 birthweight centile calculator and calculated by the trial statistician prior to data analysis Added 07/07/2022: 5. Survival to discharge without severe morbidity: defined as survival to neonatal discharge without any of the following: bronchopulmonary dysplasia, retinopathy of prematurity, severe necrotising enterocolitis, brain injury, late-onset sepsis Maternal secondary outcomes (between enrollment and delivery): 1. Proportion of women diagnosed with pre-eclampsia defined using the ISSHP definition and captured by 6 weeks post birth 2. Severe adverse maternal outcome composite defined by the fullPIERS consensus and captured by 6 weeks post birth 3. Systolic blood pressure =160 mmHg measured during routine blood pressure readings captured in maternity records and occurring on at least one occasion between study enrolment and birth of the baby 4. Concealed first repeat PlGF-based test performance (with comparison against currently utilised tests) for clinically indicated delivery for diagnosed pre-eclampsia within 14 days measured in peripheral blood samples at 1 to 3 weeks post study enrollment and analysed following completion of the trial Health economic outcomes: 1. Perinatal: intensive care, high dependency and special care unit days measured as total of these days and captured by 6 weeks post birth 2. Maternal: antenatal outpatient attendances and inpatient days; intensive care unit use measured as total numbers of each of these antenatal care epi | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLouise Webster
Outcome results
None listed