NOPE37: Angiogenic Factors for Managing Term Preeclampsia

NCT07193680 | Recruiting DMC

• 1 other identifier: PR(AMI)392-2023
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 23

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.

Conditions

Preeclampsia

Keywords

preeclampsia; angiogenic factors; expectant management

Outcome Measures

Primary Outcomes (1)

• Composite maternal outcome

  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).

  through study completion, an average of 2 months

Secondary Outcomes (13)

• Neonatal morbidity

  through study completion, an average of 2 months

• Method of delivery

  through study completion, an average of 2 months

• Maternal admission to ICU

  through study completion, an average of 2 months

• Days of maternal admission to ICU

  through study completion, an average of 2 months

• Gestational age at delivery

  through study completion, an average of 2 months

Study Arms (2)

Standard care: elective delivery at 37 weeks of gestation

ACTIVE COMPARATOR

In the control group, a blood test to assess the sFlt-1/PlGF ratio will be performed, and the result will be concealed from investigators. As in current clinical practice, elective delivery will be scheduled at 37 weeks. If preeclampsia is first diagnosed after 37 weeks, immediate delivery will be recommended. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, or oligohydramnios.

Other: Standard care: elective delivery at 37 weeks of gestation

Intervention arm: expectant management if sFlt-1/PlGF<38

EXPERIMENTAL

If sFlt-1/PlGF \<38, expectant management will be followed until 39 weeks. If any other medical condition is present, local protocols for the specific condition will be followed. If fetal growth restriction in present (with antegrade diastolic umbilical flow), weekly repetition of sFlt-1/PlGF wil be done. If sFlt-1/PlGF ≥38, delivery at 37 weeks will be recommended, or immediate delivery if the patient is enrolled after 37 weeks. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, sFlt-1/PlGF ≥38 or oligohydramnios.

Other: Intervention arm: expectant management if sFlt-1/PlGF<38

Interventions

Intervention arm: expectant management if sFlt-1/PlGF<38 OTHER

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.

Intervention arm: expectant management if sFlt-1/PlGF<38

Standard care: elective delivery at 37 weeks of gestation OTHER

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

Standard care: elective delivery at 37 weeks of gestation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Salud Carlos III: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (23)

Hospital Universitari Dexeus

Barcelona, BARCELONA, 08024, Spain

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

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Erika Bonacina, MD, PhD

CONTACT

003493 489 30 00; erika.bonacina@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 26, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

ES (23)