Screening 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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9132 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| 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) |
| Trial ID | NCT04766866 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promising results with similar screening approaches, indicating potential for success in this novel intervention.
Eligibility criteria
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 this trial is running
Liège and 20 other locations
- 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)
Study contacts
- Study coordinator: Elisa Llurba, MD; PhD
- Email: ellurba@santpau.cat
- Phone: 0034687743699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.