Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
The study aims to test the performance of the Lumella test against the sFlt/PlGF ratio (standard test) for the prediction of the risk of preeclampsia. The proposed design is a prospective cohort i.e.,
Sponsors
Advanced Global Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Potential participants include cases with a risk of preeclampsia who meet the following criteria at the time of enrolment: 1. Age of 18 years or older 2. Singleton or twin pregnancy 3. Gestational age between 24+0 to 36+6 weeks 4. Able to provide informed written consent 5. Planned delivery at the study site or where maternal and newborn records will be available to the investigator for review Cases with a risk of preeclampsia will be identified based on clinical and medical history criteria as follows: Clinical risk factors: 1. Systolic blood pressure =130 mmHg on 1 or more occasion 2. Diastolic blood pressure =80 mmHg on 1 or more occasion 3. Elevated urinary protein: 3.1. Urine protein dipstick test 1+ or more 3.2. Urinary protein/creatinine ratio =0.30 mg/mg 3.3. Urinary protein =300 mg per day in timed collection 4. New onset low platelet count =100,000 x 109/L 5. New onset elevated serum creatinine =1.0 mg/dL 6. New onset transaminase elevation above limits of normal for local laboratory 7. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses 8. New onset visual symptoms 9. Fetal growth restriction with estimated fetal weight below 10th percentile Historical/obstetrical risk factors: 1. History of preeclampsia 2. Multifetal pregnancy 3. Pre-existing hypertension 4. Pre-gestational diabetes mellitus 5. Pre-existing renal disease
Exclusion criteria
Exclusion criteria: 1. Diagnostic criteria for preeclampsia already met at the time of enrolment 2. Delivery is planned prior to 37+0 weeks of gestation for reasons other than preeclampsia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery for confirmed preeclampsia within 4 weeks of testing, collected from participants' medical records. The sensitivity for this outcome is compared between Lumella and sFLT/PLGF as non-inferiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Preeclampsia diagnosed within 7 and 28 days of sampling, collected from participants' medical records 2. Preeclampsia diagnosed later stage up to postpartum, collected from participants' medical records Results will be expressed in terms of the sensitivity and specificity of the test | — |
Countries
England, United Kingdom
Contacts
Public ContactAmarnath Bhide
Outcome results
None listed