Status:
COMPLETED
Randomizated Open-label Control Trial to Evaluate if the Incorporation of sFlt1/PlGF Ratio in the Diagnosis and Classification of PE Improves Maternal and Perinatal Outcomes in Women With the Suspicion of the Disease
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Carlos III Health Institute
Spanish Clinical Research Network - SCReN
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide. The morbidity and mortality of this condition arises from two main causes: 1) the lack of specific and sensi...
Eligibility Criteria
Inclusion
- Ability to read and understand informed consent.
- Unique pregnancies.
- \> 24 weeks and \<41 weeks
- Suspected preeclampsia:
- 140/90 or worsening of chronic hypertension
- Onset of proteinuria (Labstick + or proteinuria\> 300mg / 24 hours) or worsening of it
- Preeclampsia prodromal clinic such as epigastric, headache, photopsia, tinnitus and increased edema in the face hands or legs or weight gain (\> 1 kg per week in the third trimester)
- Analytical alterations: decrease in platelets \<100,000. Increased transaminases.
- Ultrasound alterations: Small fetus for gestational age or restriction of interatrial growth, increased resistance of the uterine arteries.
- Pre-eclampsia (ACOG Practice Bulletin 2013)
Exclusion
- Multiple pregnancies
- \<24 weeks of gestation
- Fetal chromosomal or congenital abnormalities
- Conditions that require immediate delivery (eclampsia, pulmonary edema, uncontrolled hypertension, severe visual disturbances, severe headache, fetal demise, non-reassuring fetal status….)
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2023
Estimated Enrollment :
2536 Patients enrolled
Trial Details
Trial ID
NCT03231657
Start Date
February 6 2018
End Date
November 11 2023
Last Update
December 20 2023
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025