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NCT04766866From ClinicalTrials.govRecruiting

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

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

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrolment target
9,132
Started
2 March 2021
Main results due
31 December 2026
Study sites
21
Registry updated
19 February 2025

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Nulliparous women
* Singleton pregnancies
* \>18 years old
* 35.0-36.6 weeks of gestation
* Maternal written consent form

Exclusion Criteria:

* 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.

What this study is about

In the sponsor’s own words, from the registry.

* 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.

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, India

    Recruiting

  • All India Institute of Medical Sciences (AIIMS) Ansari Nagar

    New Delhi, National Capital Territory of Delhi, India

    Recruiting

  • Vardhman Mahavir Medical College (VMMC)

    New Delhi, National Capital Territory of Delhi, 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, 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

Showing 21 of 21 sites. 8 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04766866. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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