Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT04766866

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

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-02-19

9132

Participants Needed

21

Research Sites

304 weeks

Total Duration

On this page

Sponsors

F

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

Lead Sponsor

F

Fundacion Clinic per a la Recerca Biomédica

Collaborating Sponsor

AI-Summary

What this Trial Is About

* 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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Nulliparous women
  • Singleton pregnancies
  • 18 years old or older
  • Gestational age between 35.0 and 36.6 weeks
  • Signed maternal informed consent form
Not Eligible

You will not qualify if you...

  • Fetuses or newborns with major malformations or genetic anomalies affecting delivery timing or obstetric outcome
  • Suspected fetal growth restriction defined as estimated fetal weight below 3rd percentile or between 3rd and 10th percentile with abnormal Doppler readings in uterine, umbilical, or cerebral arteries
  • Participation in another interventional study that may change delivery timing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

CHU Liège

Liège, Belgium

Active, Not Recruiting

2

Clinica del Prado SAS

Bogotá, Colombia

Actively Recruiting

3

Institute for the Care of Mother and Child

Prague, Czechia

Active, Not Recruiting

4

Medicina Fetal Quito

Quito, Ecuador

Actively Recruiting

5

Maulana Azad Medical College (MAMC)

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

Actively Recruiting

6

All India Institute of Medical Sciences (AIIMS) Ansari Nagar

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

Actively Recruiting

7

Vardhman Mahavir Medical College (VMMC)

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

Actively Recruiting

8

Hospital Gineco-Obstetricia nº4

Mexico City, Mexico

Not Yet Recruiting

9

Hospital Santo Tomas

Panama City, Panama

Actively Recruiting

10

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

Warsaw, Poland

Active, Not Recruiting

11

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Active, Not Recruiting

12

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Canary Islands, Spain

Withdrawn

13

Virgen de la Arrixaca

El Palmar, Murcia, Spain, 30120

Active, Not Recruiting

14

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Active, Not Recruiting

15

Hospital del Mar

Barcelona, Spain

Active, Not Recruiting

16

Hospital Maternitat del Clínic

Barcelona, Spain

Actively Recruiting

17

Hospital Sant Joan de Déu

Barcelona, Spain

Actively Recruiting

18

Hospital La Paz

Madrid, Spain

Withdrawn

19

Hospital Son Llatzer

Palma de Mallorca, Spain

Active, Not Recruiting

20

Hospital la Fe

Valencia, Spain

Active, Not Recruiting

21

Hospital Lozano Blesa

Zaragoza, Spain

Withdrawn

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Research Team

E

Elisa Llurba, MD; PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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