Early Onest Preeclampsia (PE)
Conditions
Interventions
Roche Elecsys reference assay
Point of care preeclampsia biomaker tests
Sponsors
Africa Clinical Research Network ACRN
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Gestational age between 23+0 and 36+6 weeks, established by ultrasound at 22 weeks or earlier. Singleton pregnancy. Clinical suspicion of preeclampsia (PE) based on one or more of the following: New onset elevated blood pressure (SBP =130 mmHg or DBP =80 mmHg). Worsening of pre existing hypertension. New onset proteinuria. Worsening of pre existing proteinuria. Other PE related symptoms or findings: Epigastric pain, severe edema, headache, visual disturbances, or sudden weight gain (>1 kg/week in 3rd trimester). Low platelets, elevated liver enzymes. Suspected IUGR or abnormal uterine Doppler (PI >95th percentile or bilateral notching). Not currently enrolled in another study or receiving an investigational product. Able and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: • Multiple pregnancy (twins, triplets, etc.). • Proteinuria =2+ on dipstick AND elevated BP (=140/90 mmHg) on two occasions. • Proteinuria =2+ on dipstick with current antihypertensive treatment. • Confirmed HELLP syndrome. • No documented ultrasound prior to 22 weeks to establish gestational age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the sFlt-1/PlGF ratio in predicting the absence or onset of PE, severe PE, eclampsia, or HELLP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between biomarker levels (sFlt-1, PlGF, sFlt-1/PlGF ratio) and maternal adverse outcomes (pulmonary edema, acute renal failure, DIC, cerebral hemorrhage, etc.). | — |
Countries
Rwanda, United Republic of Tanzania, Zimbabwe
Contacts
Public ContactRomina Mariono
Chief of Staff Africa Clinical Research Network
Outcome results
None listed