RecruitingNot ApplicableNCT04766866

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

Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term


Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Enrollment

9,132 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria3

  • 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.

Interventions

DIAGNOSTIC_TESTsFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation

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


Locations(21)

Clinica del Prado SAS

Bogotá, Colombia

CHU Liège

Liège, Belgium

Institute for the Care of Mother and Child

Prague, Czechia

Medicina Fetal Quito

Quito, Ecuador

Maulana Azad Medical College (MAMC)

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences (AIIMS) Ansari Nagar

New Delhi, National Capital Territory of Delhi, India

Vardhman Mahavir Medical College (VMMC)

New Delhi, National Capital Territory of Delhi, India

Hospital Gineco-Obstetricia nº4

Mexico City, Mexico

Hospital Santo Tomas

Panama City, Panama

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

Warsaw, Poland

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Canary Islands, Spain

Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Maternitat del Clínic

Barcelona, Spain

Hospital Sant Joan de Déu

Barcelona, Spain

Hospital La Paz

Madrid, Spain

Hospital Son Llatzer

Palma de Mallorca, Spain

Hospital la Fe

Valencia, Spain

Hospital Lozano Blesa

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04766866


Related Trials