Diagnosis of pre-term preeclampsia Pregnancy and Childbirth
Conditions
Interventions
Participants with suspected preeclampsia will be randomised to receive either a placental growth factor test, implemented alongside a clinical management algorithm (intervention), or usual care (contr
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Hypertension or other clinical suspicion of preeclampsia [such as proteinuria, abnormal blood test results suggestive of preeclampsia, small for gestational age with suspicion of preeclampsia, symptoms of preeclampsia (including headache, visual disturbances, right upper quadrant pain)] 2. Between 20- and 36+6-weeks’ gestation 3. Singleton pregnancy 4. Live pregnancy 5. Able to give informed written or thumbprint consent (or assent if aged less than 18 years with parental or guardian consent)
Exclusion criteria
Exclusion criteria: 1. In active labour (cervix dilated more than 4cm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures will be assessed from data collected from medical records at discharge, using data collected between recruitment and primary hospital discharge: 1. Primary maternal outcome: A composite of maternal mortality and morbidity (based on the miniPIERS composite of adverse maternal outcomes) during pregnancy and delivery until primary hospital discharge 2. Primary perinatal outcome: Composite of stillbirth and early neonatal death (<7 days) until primary hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed from data collected from medical records at discharge, using data collected between recruitment and primary hospital discharge: Tested Maternal Outcomes: 1. Maternal mortality according to clinical diagnosis 2. Eclampsia according to clinical diagnosis 3. Placental abruption according to clinical diagnosis 4. Termination pre-viability for maternal preeclampsia according to clinical diagnosis 5. Time to diagnosis of pre-eclampsia according to the International Society for the Study of Hypertension in Pregnancy definition 6. Proportion of women diagnosed with preeclampsia according to the International Society for the Study of Hypertension (ISSHP) in pregnancy definition 7. Time to delivery 8. Mode of birth (vaginal, assisted vaginal, caesarean section) Descriptive Maternal Outcomes: 1. Stroke 2. Cortical blindness 3. Retinal detachment 4. Pulmonary oedema 5. Acute Kidney Injury and using laboratory creatinine measurements, definition according to the KIDIGO definitions 6. Liver capsule haematoma/rupture 7. Major post-partum haemorrhage 8. Hepatic dysfunction measured according to the hospital medical records and using laboratory AST/ALT measurements, definition according to ISSHP definitions 9. Low platelets measured according to the hospital medical records and using laboratory platelet measurements, definition according to ISSHP definitions 10. ICU admission 11. Intubation and ventilation (other than for delivery) 12. Glasgow coma score 50% for more than one hour 20. Dialysis required 21. HDU admission 22. Labour onset (spontaneous, induced or pre-labour caesarean section) 23. Indication for delivery 24. Use of MgSO4 25. Use of steroids 26. Use of antihypertensives 27. Parenteral infusion of third-line antihypertensives required Perinatal Outcomes Tested Perinatal Outcomes 1. Stillbirth 2. Early neonatal death (within 7 days of life) 3. Neonatal unit admission 4. Neonatal unit ad | — |
Countries
Brazil, India, Sierra Leone, Zambia
Contacts
Public ContactLouisa Samuels
Outcome results
None listed