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Recruiting NCT07193680

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

Trial Parameters

Condition Preeclampsia
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 750
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-12-04
Completion 2027-12
Interventions
Intervention arm: expectant management if sFlt-1/PlGF<38Standard care: elective delivery at 37 weeks of gestation

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 rate of progression to preeclampsia with severe features and other maternal complications.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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