Status:
RECRUITING
NOPE37: Angiogenic Factors for Managing Term Preeclampsia
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study tests the hypothesis that, in women with preeclampsia without severe features, delivery management based on sFlt-1/PlGF would reduce the rate of induction of labor without worsening the rat...
Detailed Description
Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups: * In the study group, if angiogenic ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Singleton pregnancy
- Preeclampsia without severe features according to the ACOG definition
- Antegrade diastolic flow in the umbilical artery Doppler
- Gestational age between 36+0 and 38+6 weeks of gestation
- Gestational age confirmed by fetal crown-rump length measurement in the first-trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates
Exclusion
- Fetal death
- Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery
- Absent or reversed end-diastolic flow in the umbilical artery Doppler
- Non-reassuring CTG
- Decreased fetal movements
- Biophysical profile score ≤6
- Oligohydramnios
- Refusal to provide informed consent
- Fetal malformation
- Placental abruption
- Antiphospholipid antibody syndrome
Key Trial Info
Start Date :
December 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07193680
Start Date
December 4 2025
End Date
April 1 2028
Last Update
December 11 2025
Active Locations (23)
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1
Hospital Universitari Dexeus
Barcelona, BARCELONA, Spain, 08024
2
Hospital Universitario de A Coruña
A Coruña, Spain
3
Hospital General Universitari Dr. Balmis
Alicante, Spain
4
Vall d'Hebron Hospital Campus
Barcelona, Spain