NCT04766866 sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
| NCT ID | NCT04766866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,132 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9,132 participants in total. It began in 2021-03-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04766866 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04766866 currently recruiting?
Yes, NCT04766866 is actively recruiting participants. Contact the research team at ellurba@santpau.cat for enrollment information.
Where is the NCT04766866 trial being conducted?
This trial is being conducted at Liège, Belgium, Bogotá, Colombia, Prague, Czechia, Quito, Ecuador and 11 additional locations.
Who is sponsoring the NCT04766866 clinical trial?
NCT04766866 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 9,132 participants.