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

NCT04766866 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9132

Last updated 2025-02-19

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

sFlt1/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

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Belgium
  • Colombia
  • Czechia
  • Ecuador
  • India
  • Mexico
  • Panama
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766866 on ClinicalTrials.gov