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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether checking a specific blood protein (called sFlt1/PlGF) can help doctors decide the safest time to deliver babies for first-time mothers at risk of a serious pregnancy complication called preeclampsia (dangerously high blood pressure in late pregnancy). You may be eligible if: - You are pregnant with your first baby (no previous births) - You are carrying a single baby (not twins or more) - You are over 18 years old - You are between 35 and 36 weeks and 6 days pregnant - You are willing to give written consent You may NOT be eligible if: - Your baby has a known major birth defect or genetic condition that could affect when delivery happens - Your baby is suspected to have growth problems or abnormal blood flow patterns detected on ultrasound - You are already taking part in another study that could affect the timing of your delivery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

CHU Liège

Liège, Belgium

Clinica del Prado SAS

Bogotá, Colombia

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

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NCT04766866


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