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Studies

Interventional Recruiting

NCT05521776 on ClinicalTrials.gov

Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)

Official title: Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity : a Multicenter Randomized Trial

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Collaborators: INSERM, Epopé team, URC-CIC Paris Descartes Necker Cochin
  • Enrollment: 14500 (Estimated)
  • Study start: 2023-03-06 (Actual)
  • Primary completion: 2026-08-01 (Estimated)
  • Study completion: 2027-02-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Screening

Brief Summary

The purpose of this study is to determine whether first-trimester screening for preeclampsia based on the FMF algorithm (a combination of maternal clinical, sonographic and biochemical parameters), improves maternal or perinatal health.

Conditions

  • Preeclampsia (PE)

Intervention / Treatment

  • Procedure: First-trimester preeclampsia screening (FMF triple test)

Primary Outcome Measures

  • Severe perinatal morbidity (From birth up to 7 days of life)
    The primary outcome will be severe perinatal morbidity defined by a composite criterion including at least one of the following: * perinatal mortality (stillbirth ≥ 20 WG or with birth weight \> 500 g or neonatal death within 7 days of life) or prematurity \< 34 WG or birth weight \< 3° percentile. * prematurity \< 34 WG: birth before ≥ 34 WG * birth weight \< 3° percentile

Countries

France

Locations and Investigators

  • CHU Angers, Angers, France (Recruiting)
    • Guillaume LEGENDRE
  • CHU de Bordeaux, Bordeaux, France (Recruiting)
    • Loïc SENTILHES, Pr
  • Hôpital Femme Mère Enfant, Bron, France (Recruiting)
    • Anthony ATTALAH, Dr
  • Hôpital Antoine Béclère, Clamart, France (Recruiting)
    • Alexandra LETOURNEAU, Dr
  • CHU Estaing, Clermont-Ferrand, France (Recruiting)
    • Denis GALOT, Dr
  • Hôpital Intercommunal Créteil, Créteil, France (Recruiting)
    • Edouard LECARPENTIER, Dr
  • CHU Dijon Bourgogne, Dijon, France (Recruiting)
    • Emmanuel SIMON, Dr
    • Emmanuel.Simon@u-bourgogne.fr
  • CHU Lille, Lille, France (Recruiting)
    • Louise GHESQUIERE, PhD
  • Hôpital de la conception et de la Timone, Marseille, France (Recruiting)
    • Florence BRETELLE, Pr
  • Hôpital Nord, Marseille, France (Recruiting)
    • Julie BLANC, Dr
  • CHRU de Nancy, Nancy, France (Recruiting)
  • Hôpital Femme - Maternité, Nantes, France (Recruiting)
    • Norber WINER, Pr
  • Hôpital Armand Trousseau, Paris, France (Recruiting)
    • Gilles KAYEM, Pr
  • Hôpital Cochin (site Port-Royal), Paris, France (Recruiting)
    • Vassilis TSATSARIS, Pr
  • Hôpital Saint-Joseph, Paris, France (Recruiting)
    • Elie AZRIA, Pr
  • CHI de Poissy, Poissy, France (Recruiting)
    • Paul BERVEILLER, Pr
  • Hôpital Sud Rennes, Rennes, France (Recruiting)
    • Maela LELOUS, Dr
  • CHU Charles Nicolle, Rouen, France (Recruiting)
    • Eric VERSPYCK, Pr
  • CHU Strasbourg, CMCO Schiltigheim, Strasbourg, France (Recruiting)
    • AS WEINGERTNER, Dr
  • Hôpital de Hautepierre, Strasbourg, France (Recruiting)
    • Anne-Sophie WEINGERTNER, Dr
  • Hôpital Paule de Viguier, Toulouse, France (Recruiting)
    • Paul GUERBY, Dr
  • Hôpital Bretonneau, Tours, France (Recruiting)

Study Officials