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sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.

Study acronym: PE37
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026
    • Study sites: 17 to 21
    v8
  2. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2024v7 Show 6 more changesShow less
    • Study sites: 14 to 17
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description expanded, about 31 words
    • Study title shortened, about 1 word
  3. Notable Primary endpoint revised
    • Interventions: sFlt1/PlGF screening in maternal blood at 35 to 37 weeks of gestation (Diagnostic Test) to sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation (Diagnostic Test)
    • Eligibility criteria expanded, about 9 words
    v6
  4. Minor Site details revised at 2 of 14 sitesv5
  5. Minor Site details revised at 7 of 14 sitesv4
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  1. Minor Site details revised at 1 of 14 sitesv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2021 to Mar 2, 2021
    • Site details revised at 14 of 14 sites
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
* 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.
Trial Details
NCT Number NCT04766866
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Fundacion Clinic per a la Recerca Biomédica
Conditions
(from sponsor)
Preeclampsia, Intrauterine Growth Restriction, Maternal Hypertension, Neonatal Outcome, Perinatal Death
Related terms Fetal Growth Retardation, Hypertension, Pregnancy-Induced, Perinatal Death, Pre-Eclampsia
Enrollment 9,132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov