sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.

NCT04766866 | Recruiting DMC

• 1 other identifier: PE37
• Study Type: interventional
• Target: 9,132
• Locations: 9 countries
• Sites: 21

Brief Summary

• Preeclampsia (PE) affects \~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world.
• Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved.
• Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings.
• Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate.
• Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe.
• The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes.
• The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of \>90th centile will be used to define high risk of PE and offer IOL from 37w.
• If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

Conditions

Preeclampsia; Intrauterine Growth Restriction; Maternal Hypertension; Neonatal Outcome; Perinatal Death

Keywords

Preeclampsia, angiogenic factors, perinatal death, induction of labour

Outcome Measures

Primary Outcomes (1)

• Rate of term Preeclampsia development

  Number of participants with term preeclampsia/total number participants.

  4 weeks

Secondary Outcomes (8)

• Maternal morbidity rate

  6 weeks

• Maternal Hospital stay

  6 weeks

• Caesarean section rate

  4 weeks

• Perinatal complications rate

  18 weeks

• Neonatal hospital stay

  18 weeks

Study Arms (2)

Non-intervention or non-reveal group

NO INTERVENTION

Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery

Intervention group or reveal group

EXPERIMENTAL

A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation

Diagnostic Test: sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation

Interventions

sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation DIAGNOSTIC_TEST

A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation

Intervention group or reveal group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women
• Singleton pregnancies
• \>18 years old
• weeks of gestation
• Maternal written consent form

You may not qualify if:

• Fetuses/neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome
• Suspected fetal growth restriction (estimated fetal weight \<3 centile or between the 3rd and 10th centile together with abnormal Doppler in the mean uterine artery Doppler pulsatility index, or in umbilical artery pulsatility index or in the middle cerebral artery or in the cerebral umbilical index (CPR))
• Participation in another interventional study that could modify the timing of delivery.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (21)

CHU Liège

Liège, Belgium

ACTIVE NOT RECRUITING

Clinica del Prado SAS

Bogotá, Colombia

RECRUITING

Institute for the Care of Mother and Child

Prague, Czechia

ACTIVE NOT RECRUITING

Medicina Fetal Quito

Quito, Ecuador

RECRUITING

Maulana Azad Medical College (MAMC)

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

All India Institute of Medical Sciences (AIIMS) Ansari Nagar

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Vardhman Mahavir Medical College (VMMC)

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Hospital Gineco-Obstetricia nº4

Mexico City, Mexico

NOT YET RECRUITING

Hospital Santo Tomas

Panama City, Panama

RECRUITING

Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine

Warsaw, Poland

ACTIVE NOT RECRUITING

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Canary Islands, Spain

WITHDRAWN

Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

ACTIVE NOT RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital del Mar

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Maternitat del Clínic

Barcelona, Spain

RECRUITING

Hospital Sant Joan de Déu

Barcelona, Spain

RECRUITING

Hospital La Paz

Madrid, Spain

WITHDRAWN

Hospital Son Llatzer

Palma de Mallorca, Spain

ACTIVE NOT RECRUITING

Hospital la Fe

Valencia, Spain

ACTIVE NOT RECRUITING

Hospital Lozano Blesa

Zaragoza, Spain

WITHDRAWN

Related Publications (1)

• Llurba E, Crispi F, Crovetto F, Youssef L, Delgado JL, Puig I, Mora J, Krofta L, Mackova K, Martinez-Varea A, Tubau A, Ruiz A, Paya A, Prat M, Chantraine F, Comas C, Kajdy A, Lopez-Tinajero MF, Figueras F, Gratacos E; PE37 study group. Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study. BMJ Open. 2024 Mar 8;14(3):e076201. doi: 10.1136/bmjopen-2023-076201.

  PMID: 38458783 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Hypertension, Pregnancy-Induced; Perinatal Death

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Death

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Elisa Llurba, MD; PhD

CONTACT

0034687743699; ellurba@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Upon agreement to participate in this study, patients will be randomized to one of the following groups: • Intervention group or reveal group (sFlt-1/PlGF result known to clinicians). A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetric and Gynecology Universitat Autònoma de Barcelona

Model Details: Prospective, open-label randomized study with parallel groups.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 23, 2021
• Study Start: March 2, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

PA (1); ES (11); EC (1); CZ (1); CO (1); IN (3); ME (1); PL (1); BE (1)