Ireland
--:--IST
Recruiting Not applicable

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

NCT07193680 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-12-04
Last updated
2025-12-11

Condition(s) studied

Preeclampsia

Investigational drug(s) / intervention(s)

Intervention arm: expectant management if sFlt-1/PlGF<38Standard care: elective delivery at 37 weeks of gestation

Intervention arm: expectant management if sFlt-1/PlGF<38: If the angiogenic factors are normal (sFlt-1/PlGF \<38), expectant management will be followed until 39 weeks, instead of delivery at ≥37 weeks of gestation as in standard care for preeclampsia without severe features.

Standard care: elective delivery at 37 weeks of gestation: In the control arm, standard care for preeclampsia without severe features will be followed: elective delivery at ≥37 weeks of gestation.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite maternal outcome — through study completion, an average of 2 months
    The primary outcome is a composite poor maternal outcome, defined as maternal mortality, severe maternal morbidity (eclampsia, HELLP syndrome, thromboembolic disease, pulmonary edema, or placental abruption), preeclampsia with severe features, and major postpartum hemorrhage (\>1000 mL).

Trial sites (23)

FacilityCityRegionStatus
Hospital Universitari Dexeus Barcelona BARCELONA Recruiting
Hospital Universitario de A Coruña A Coruña Spain Recruiting
Hospital General Universitari Dr. Balmis Alicante Spain Recruiting
Vall d'Hebron Hospital Campus Barcelona Spain Recruiting
Hospital Universitario de Cabueñes Cabueñes Spain Recruiting
Hospital Universitario Puerta del Mar Cadiz Spain Recruiting
Hospital General Universitario de Elche Elche Spain Recruiting
Hospital Universitario de Getafe Getafe Spain Recruiting
Hospital Universitari de Girona Doctor Josep Trueta Girona Spain Recruiting
Hospital Universitario San Cecilio Granada Spain Recruiting
Hospital Universitario de Jerez Jerez de la Frontera Spain Recruiting
Hospital Materno Infantil de Gran Canaria Las Palmas de Gran Canaria Spain Recruiting
Hospital Universitari Arnau de Vilanova Lleida Spain Recruiting
Hospital universitario 12 de Octubre Madrid Spain Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain Recruiting
Hospital Universitari Son Espases Palma de Mallorca Spain Recruiting
Hospital Universitario Virgen de Valme Seville Spain Recruiting
Hospital Universitario Virgen Macarena Seville Spain Recruiting
Hospital Universitari de Tarragona Joan XXIII Tarragona Spain Recruiting
Consorci Sanitari de Terrassa Terrassa Spain Recruiting
Hospital Universitari MútuaTerrassa Terrassa Spain Recruiting
Hospital Universitario de Torrejón Torrejón Spain Recruiting
Hospital Universitario Lozano Blesa Zaragoza Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07193680 on ClinicalTrials.gov ↗ ← All trials in Spain