Condition: Preeclampsia · Intrauterine Growth Restriction · Maternal Hypertension · Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
* 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 prevale…
This description comes directly from the study's public registry record.
Elisa Llurba, MD; PhD · 0034687743699 · ellurba@santpau.cat
Always discuss trial participation with your own doctor first.
| 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 |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04766866