RecruitingNot ApplicableNCT07193680

NOPE37: Angiogenic Factors for Managing Term Preeclampsia

Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

750 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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

Interventions

OTHERIntervention 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.

OTHERStandard 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.


Locations(23)

Hospital Universitari Dexeus

Barcelona, BARCELONA, Spain

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital General Universitari Dr. Balmis

Alicante, Spain

Vall d'Hebron Hospital Campus

Barcelona, Spain

Hospital Universitario de Cabueñes

Cabueñes, Spain

Hospital Universitario Puerta del Mar

Cadiz, Spain

Hospital General Universitario de Elche

Elche, Spain

Hospital Universitario de Getafe

Getafe, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Hospital Universitario San Cecilio

Granada, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Hospital Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital universitario 12 de Octubre

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Consorci Sanitari de Terrassa

Terrassa, Spain

Hospital Universitari MútuaTerrassa

Terrassa, Spain

Hospital Universitario de Torrejón

Torrejón, Spain

Hospital Universitario Lozano Blesa

Zaragoza, Spain

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NCT07193680


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