Scholarlink

Background <p>Preeclampsia (PE) affects 2–8% of pregnant women and is a leading cause of maternal and perinatal morbidity and mortality. In high-risk pregnant women, low-dose aspirin (LDA 100—160&#xa0;mg/day) started before 16 WG reduces the incidence of PE, prematurity, perinatal mortality and low birth weight. First trimester screening of PE allows the identification of a population of pregnant women at high risk of early onset PE and perinatal mortality. It remains unclear whether, on a population scale, the systematic implementation of first trimester screening of PE with treatment of high-risk patients by LDA leads to an improvement of maternal and perinatal health.</p> Methods <p>This multicenter open randomized controlled trial with two parallel groups will include 14,500 pregnant women between 11–14 WG. Eligible women agreeing to participate in the trial will be randomized either to the experimental group with management including screening of PE, or to the control group with usual care without screening of PE. For women in the screening group, the risk of PE will be calculated according to an algorithm combining clinical characteristics, uterine arteries Doppler profile and PlGF concentration. Women with a positive screening test (i.e. predicted risk &gt; 1/100) will receive aspirin at 160&#xa0;mg/day. For women with negative screening, usual pregnancy monitoring without aspirin will be offered. The primary outcome is a composite of severe perinatal morbidity including at least one of the following: perinatal mortality, birth before 34 WG and birth weight &lt; 3rd centile. Secondary endpoints include maternal morbidity and mental health outcomes, and a cost-effectiveness evaluation. This study will have a 90% power to show a 50% reduction of the primary outcome in at-risk women, expected to represent 10% of the total population in each group, i.e. an overall expected 3% frequency of the primary outcome in the intervention group as a whole versus 4% in the control group.</p> Discussion <p>This large multicenter randomized trial aims to determine with adequate power if the implementation of first trimester PE screening in all pregnant women would decrease the incidence of perinatal mortality, prematurity before 34 WG and birth weight &lt; 3rd centile.</p> Trial registration <p>ClinicalTrials.gov NCT 05521776 (August 30, 2022).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Impact of first-trimester preeclampsia screening on perinatal and maternal morbidity: the RANSPRE open multicenter randomized trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月20日

查看全文
  • Vassilis Tsatsaris,
  • Jean Guibourdenche,
  • Catherine Deneux-Tharaux,
  • Natasha Caretti,
  • Marie-Clémence Leguy,
  • Mathilde Pace,
  • Loïc Sentilhes,
  • Julie Brossaud,
  • Marine Agnola,
  • Louise Guesquière,
  • Gilles Renom,
  • Isis Cacho,
  • Julie Blanc,
  • Florence Bretelle,
  • Annie Levy,
  • Justine Vacher,
  • Olivier Morel,
  • Sophie Orlowski,
  • Marie Hoffstetter,
  • Alexandra Letourneau,
  • Samra Lounis,
  • Norbert Winer,
  • Damien Masson,
  • Morgane Vincke,
  • Paul Berveiller,
  • Magali Annette-Reisch,
  • Noémie Hot,
  • Eric Verspyck,
  • Hélène Girot,
  • Alexandra Collins,
  • Anne Sophie Weingertner,
  • Sarah Romain,
  • Agate Le Mellec,
  • Franck Perrotin,
  • Eric Piver,
  • Marie Liesse Derrode,
  • Gilles Kayem,
  • Sihame Meziati Boukhari,
  • Elie Azria,
  • Morgane Revel,
  • Denis Gallot,
  • Geoffroy Marceau,
  • Antony Atallah,
  • Magali Pettazzoni,
  • Anne Leroux,
  • Edouard Lecarpentier,
  • Diane Redel,
  • Maëla Le Lous,
  • Corinne Sault,
  • Paul Guerby,
  • Safouane Hamdi,
  • Delphine Duchanois,
  • Emmanuel Simon,
  • Stephanie Lemaire,
  • Sophie Godart,
  • Guillaume Legendre,
  • Valérie Moal,
  • Charline Placais,
  • Shohreh Azimi,
  • Hendy Abdoul,
  • Alice Camara,
  • Valérie Plence,
  • Victoria Buth-Guillemart,
  • Isabelle Durand-Zaleski,
  • Kevin Zarca,
  • Céline Camilleri,
  • Delphine Simons,
  • Aurelien Seco

摘要

Background

Preeclampsia (PE) affects 2–8% of pregnant women and is a leading cause of maternal and perinatal morbidity and mortality. In high-risk pregnant women, low-dose aspirin (LDA 100—160 mg/day) started before 16 WG reduces the incidence of PE, prematurity, perinatal mortality and low birth weight. First trimester screening of PE allows the identification of a population of pregnant women at high risk of early onset PE and perinatal mortality. It remains unclear whether, on a population scale, the systematic implementation of first trimester screening of PE with treatment of high-risk patients by LDA leads to an improvement of maternal and perinatal health.

Methods

This multicenter open randomized controlled trial with two parallel groups will include 14,500 pregnant women between 11–14 WG. Eligible women agreeing to participate in the trial will be randomized either to the experimental group with management including screening of PE, or to the control group with usual care without screening of PE. For women in the screening group, the risk of PE will be calculated according to an algorithm combining clinical characteristics, uterine arteries Doppler profile and PlGF concentration. Women with a positive screening test (i.e. predicted risk > 1/100) will receive aspirin at 160 mg/day. For women with negative screening, usual pregnancy monitoring without aspirin will be offered. The primary outcome is a composite of severe perinatal morbidity including at least one of the following: perinatal mortality, birth before 34 WG and birth weight < 3rd centile. Secondary endpoints include maternal morbidity and mental health outcomes, and a cost-effectiveness evaluation. This study will have a 90% power to show a 50% reduction of the primary outcome in at-risk women, expected to represent 10% of the total population in each group, i.e. an overall expected 3% frequency of the primary outcome in the intervention group as a whole versus 4% in the control group.

Discussion

This large multicenter randomized trial aims to determine with adequate power if the implementation of first trimester PE screening in all pregnant women would decrease the incidence of perinatal mortality, prematurity before 34 WG and birth weight < 3rd centile.

Trial registration

ClinicalTrials.gov NCT 05521776 (August 30, 2022).