Blood test and planned delivery for late pregnancy preeclampsia in first-time mothers
Tests a blood screening test and planned delivery in first-time pregnant adults.
Plain-language title generated from the registry record
Registry title: sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
Key facts
- Where
- Badalona, Barcelona, El Palmar, Las Palmas de Gran Canaria, Madrid, Palma de Mallorca, Valencia, and Zaragoza, SpainSee the 11 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for first-time pregnant women, over 18, carrying one baby at 35.0-36.6 weeks. It tests a blood screening for preeclampsia followed by labour induction from 37 weeks.
- Age
- Over 18 years old (minimum 18 Years).
- Sex
- Women only.
- Disease stage
- Pregnant for the first time, one baby, at 35.0-36.6 weeks of pregnancy.
- Biomarker or test result
- The sFlt1/PlGF ratio in the mother's blood is measured at 35-36.6 weeks. A ratio above the 90th centile is counted as high risk.
Main reasons for not taking part
- Baby with a major malformation or genetic anomaly that could change the timing of delivery or the birth outcome
- Suspected poor growth of the baby, including abnormal Doppler findings
- Taking part in another trial that could change the timing of delivery
- Having given birth before
This trial only enrols pregnant participants. The registry sentence this rests on: 35.0-36.6 weeks of gestation
Read by machine on 12 November 2026.
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital Maternitat del ClínicBarcelona, SpainContact: Francesc FiguerasTaking people
- Hospital Sant Joan de DéuBarcelona, SpainContact: Francesc FiguerasTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital del MarBarcelona, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Virgen de la ArrixacaEl Palmar, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Complejo Hospitalario Universitario Insular Materno InfantilLas Palmas de Gran Canaria, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital La PazMadrid, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital Son LlàtzerPalma de Mallorca, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital La FeValencia, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
- Hospital Lozano BlesaZaragoza, SpainContact: Elisa Llurba, MD; PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Trial code
- NCT04766866
- Record updated
- 19 February 2025
- Original description
* 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.Read full original descriptionShow less
Protocol of the PE37 Study: A Multicenter Randomized Trial of Screening With sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term
* 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.
Inclusion: Nulliparous women; Singleton pregnancies; >18 years old; 35.0-36.6 weeks of gestation; Maternal written consent form.
Exclusion: 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.