sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
Recruiting now · Not applicable
Conditions studied: Preeclampsia, Intrauterine Growth Restriction, Maternal Hypertension, Neonatal Outcome, Perinatal Death
In brief
* 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.
Key facts
- Study ID
- NCT04766866
- Run by
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- People needed
- 9132
- Starts
- 2021-03-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-02-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Nulliparous women
- Singleton pregnancies
- >18 years old
- 35.0-36.6 weeks of gestation
- Maternal written consent form
You may not qualify if…
- 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 is running
- Clinica del Prado SAS — Bogotá, Colombia (enrolling)
- Hospital Santo Tomas — Panama City, Panama (enrolling)
- Hospital Maternitat del Clínic — Barcelona, Spain (enrolling)
- Hospital Sant Joan de Déu — Barcelona, Spain (enrolling)
- Medicina Fetal Quito — Quito, Ecuador (enrolling)
- Maulana Azad Medical College (MAMC) — New Delhi, National Capital Territory of Delhi, India (enrolling)
- All India Institute of Medical Sciences (AIIMS) Ansari Nagar — New Delhi, National Capital Territory of Delhi, India (enrolling)
- Vardhman Mahavir Medical College (VMMC) — New Delhi, National Capital Territory of Delhi, India (enrolling)
- Hospital del Mar — Barcelona, Spain
- Hospital La Paz — Madrid, Spain
- Hospital Son Llatzer — Palma de Mallorca, Spain
- Hospital la Fe — Valencia, Spain
- CHU Liège — Liège, Belgium
- Hospital Lozano Blesa — Zaragoza, Spain
- Institute for the Care of Mother and Child — Prague, Czechia
- Hospital Gineco-Obstetricia nº4 — Mexico City, Mexico
- Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine — Warsaw, Poland
- Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
- Complejo Hospitalario Universitario Insular Materno Infantil — Las Palmas de Gran Canaria, Canary Islands, Spain
- Virgen de la Arrixaca — El Palmar, Murcia, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
Full record on ClinicalTrials.gov
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