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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