Actively Recruiting
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
Eligibility Criteria
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
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
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
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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