Screening and planned delivery to prevent preeclampsia at term
Official title: Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term
Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT04766866 · Data updated 2026-11-12
This study is testing a new blood test to see if it can help predict preeclampsia in first-time pregnant women and if inducing labor early can lower the chances of complications for both mom and baby.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 9132 (estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 21 sites (Liège and 20 other locations) |
| Status | Recruiting |
| Started | March 2, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT04766866 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are nulliparous women over 18 years old with singleton pregnancies between 35.0 and 36.6 weeks of gestation.
✕Probably not a fit
Patients with fetuses/neonates that have major malformations or genetic anomalies, or those suspected of fetal growth restriction, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate a single-step screening method using the sFlt1/PlGF ratio in maternal blood at 35-36 weeks of gestation to predict term preeclampsia (PE). If detected, the study proposes to induce labor from 37 weeks to reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. The approach is designed to be pragmatic and applicable in various healthcare settings, particularly in those with limited resources. The study focuses on nulliparous women with singleton pregnancies who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of term preeclampsia and improve maternal and neonatal outcomes.
How similar studies have gone: Previous studies have shown promising results with similar screening approaches, indicating potential for success in this novel intervention.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Clinica del Prado SAS
Bogotá, Colombia 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 Santo Tomas
Panama City, Panama Recruiting
Show 15 more locations
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Hospital Maternitat del Clínic
Barcelona, Spain Recruiting -
Hospital Sant Joan de Déu
Barcelona, Spain Recruiting -
CHU Liège
Liège, Belgium Active not recruiting -
Institute for the Care of Mother and Child
Prague, Czechia Active not recruiting -
Hospital Gineco-Obstetricia nº4
Mexico City, Mexico Not yet 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 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
Study contacts
- Study coordinator: Elisa Llurba, MD; PhD
- Email: ellurba@santpau.cat
- Phone: 0034687743699
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using aspirin to prevent complications in pregnant women with chronic hypertension
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-
Using ultrasound to improve detection of fetal growth issues
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-
Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation
This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.
-
Internal jugular vein collapsibility to gauge volume status in preeclampsia vs. normal pregnancy
This study tests whether ultrasound of the internal jugular vein can show differences in fluid status between preeclamptic pregnant people and those with normal blood pressure during planned cesarean delivery.
-
Higher vs lower daily aspirin in high-risk pregnant people
This study tests whether taking 150 mg of aspirin daily is more effective than 75 mg daily in preventing preeclampsia among pregnant people at high risk.
-
Community health worker support to lower blood pressure after pregnancy with high blood pressure
Postpartum patients with high blood pressure after pregnancy will try a program where a trained community health worker helps them monitor blood pressure and manage care for 6 months to see if it lowers blood pressure compared with usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.