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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Nulliparous women

• Singleton pregnancies

• \>18 years old

• 35.0-36.6 weeks of gestation

• Maternal written consent form

Locations
Other Locations
Belgium
CHU Liège
ACTIVE_NOT_RECRUITING
Liège
Colombia
Clinica del Prado SAS
RECRUITING
Bogotá
Ecuador
Medicina Fetal Quito
RECRUITING
Quito
India
All India Institute of Medical Sciences (AIIMS) Ansari Nagar
RECRUITING
New Delhi
Maulana Azad Medical College (MAMC)
RECRUITING
New Delhi
Vardhman Mahavir Medical College (VMMC)
RECRUITING
New Delhi
Mexico
Hospital Gineco-Obstetricia nº4
NOT_YET_RECRUITING
Mexico City
Panama
Hospital Santo Tomas
RECRUITING
Panama City
Poland
Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Hospital Germans Trias i Pujol
ACTIVE_NOT_RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital del Mar
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Maternitat del Clínic
RECRUITING
Barcelona
Hospital Sant Joan de Déu
RECRUITING
Barcelona
Virgen de la Arrixaca
ACTIVE_NOT_RECRUITING
El Palmar
Complejo Hospitalario Universitario Insular Materno Infantil
WITHDRAWN
Las Palmas De Gran Canaria
Hospital La Paz
WITHDRAWN
Madrid
Hospital Son Llatzer
ACTIVE_NOT_RECRUITING
Palma De Mallorca
Hospital la Fe
ACTIVE_NOT_RECRUITING
Valencia
Hospital Lozano Blesa
WITHDRAWN
Zaragoza
Contact Information
Primary
Elisa Llurba, MD; PhD
ellurba@santpau.cat
0034687743699
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 9132
Treatments
No_intervention: Non-intervention or non-reveal group
Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery
Experimental: Intervention group or reveal group
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
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

This content was sourced from clinicaltrials.gov