A parallel-group diagnostic, non-interventional, blinded, 2-arm study to investigate the predictive accuracy of angiogenic biomarkers (sFlt-1/PlGF ratio and soluble endoglin) using point-of-care platforms compared with reference laboratory assays in pregnant female participants aged 18 years and above at 35+1 to 36+6 weeks’ gestation with suspected late-onset preeclampsia in Nigerian tertiary and secondary hospitals.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606852536033

Enrollment

1250

Registered

2026-06-26

Start date

2026-03-09

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Onset Preeclampsia

Interventions

Roche Elecsys reference assay with RD Quantikine ELISA

Point of care diagnostic platforms GRAVIDAS and PEscreen

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Age =18 years Singleton pregnancy Gestational age 35+1 to 36+6 weeks (=10% =37 weeks) Gestational age confirmed by ultrasound performed before 22 weeks Clinical suspicion of late-onset preeclampsia (LOPE) based on at least one of: • Elevated BP (systolic =130 mmHg or diastolic =80 mmHg) • Aggravation of pre-existing hypertension • New onset of proteinuria • Aggravation of pre-existing proteinuria • Preeclampsia-related symptoms (headache, visual disturbances, epigastric pain, swelling, rapid weight gain >1 kg/week) • Preeclampsia-related findings (low platelets, elevated liver enzymes, suspected IUGR, abnormal uterine Doppler) Willing and able to provide informed consent Not enrolled in any other interventional clinical study

Exclusion criteria

Exclusion criteria: Multiple gestation (twins, triplets, etc.) Proteinuria =2+ (dipstick) AND BP =140/90 mmHg AND currently on antihypertensive therapy Confirmed HELLP syndrome Eclampsia or currently receiving magnesium sulfate therapy Major comorbidity requiring immediate delivery (e.g., placental abruption, severe anemia Hb <7.0 g/dL, active infection) No ultrasound performed before 22 weeks to confirm gestational age Concurrent participation in another interventional study

Design outcomes

Primary

Measure	Time frame
Negative Predictive Value (NPV) and Sensitivity of angiogenic biomarker thresholds (sFlt-1/PlGF ratio and sEng) for ruling out preeclampsia/eclampsia/HELLP within 1 week;Positive Predictive Value (PPV) and Specificity of angiogenic biomarker thresholds (sFlt-1/PlGF ratio and sEng) for ruling in preeclampsia/eclampsia/HELLP within 2 and 4 weeks	—

Secondary

Measure	Time frame
Composite maternal adverse outcome (ICU admission, HELLP, eclampsia, pulmonary edema, renal failure, stroke/cerebral hemorrhage, DIC, maternal death) within 14 days of testing, associated with baseline biomarker levels/POC classifications.;Composite neonatal adverse outcome (preterm birth <37 weeks, fetal growth restriction, NICU admission, stillbirth or neonatal death, RDS/TTN, IVH, NEC).;Change (absolute and relative) in sFlt-1/PlGF ratio and sEng between Visit 1 and Visit 2 as a predictor of disease progression within 14 days.	—

Measure

Time frame

Composite maternal adverse outcome (ICU admission, HELLP, eclampsia, pulmonary edema, renal failure, stroke/cerebral hemorrhage, DIC, maternal death) within 14 days of testing, associated with baseline biomarker levels/POC classifications.;Composite neonatal adverse outcome (preterm birth <37 weeks, fetal growth restriction, NICU admission, stillbirth or neonatal death, RDS/TTN, IVH, NEC).;Change (absolute and relative) in sFlt-1/PlGF ratio and sEng between Visit 1 and Visit 2 as a predictor of disease progression within 14 days.

—

Countries

Nigeria

Contacts

Public ContactRomina Mariono

Chief Of Staff ACRN

romina.mariono@acrnhealth.com+27797445305

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026