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Background <p>The ARRIVE trial showed that elective induction of labor at 39&#xa0;weeks for low-risk nulliparous women compared to expectant management reduced cesarean delivery rates with a nonsignificant trend toward decreased perinatal morbidity. However, the generalizability of these findings to other health care systems and obstetric contexts outside of the United States remains uncertain.</p> Methods <p>The FRENCH-ARRIVE multicenter, randomized controlled trial with two parallel groups, modeled on the ARRIVE trial, will include 4200 low-risk nulliparous women with singleton pregnancies from 37 weeks 0 days through 38 weeks 6 days of gestation. Women will be randomized in a 1:1 ratio to either elective induction between 39 weeks 0 days and 39 weeks 4 days of gestation or expectant management. The primary outcome will be the incidence of cesarean deliveries after randomization, regardless of indication. This study will have a power of 80% to show a 20% reduction in the cesarean incidence from 15.0% to 12.0%. Secondary outcomes will include indicators of maternal and perinatal morbidity and of health-care resource utilization, defined consistently with those of the ARRIVE trial to allow meaningful comparisons.</p> Discussion <p>This large, multicenter, randomized controlled trial, as the first replication of the ARRIVE trial in a different setting, aims to compare the effect of elective induction of labor at 39 weeks of gestation <i>versus</i> expectant management on the incidence of cesarean delivery in low-risk nulliparous women.</p> Trial registration <p>ClinicalTrials.gov NCT04799912 (March 12, 2021).</p>

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Study protocol FRENCH-ARRIVE: labor induction in low-risk nulliparous women at 39 weeks of gestation to reduce cesarean births: a randomized trial of induction versus expectant management in France

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  • 发表日期：

    2026年5月8日

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  • Hugo Madar,
  • Jean-Marie Chrétien,
  • Hanane Bouchghoul,
  • Alizée Froeliger,
  • Aline Bibes,
  • Caroline Lacoste,
  • Damien Subtil,
  • Patrick Saulnier,
  • Loïc Sentilhes,
  • Léa Milan,
  • Aurélie Rigaud,
  • Sophie Regueme,
  • Sandrine Desjardins,
  • Guillaume Legendre,
  • Nicolas Mottet,
  • Denis Gallot,
  • Raoul Desbrière,
  • Florent Fuchs,
  • Olivier Morel,
  • Vincent Letouzey,
  • François Goffinet,
  • Camille Le Ray,
  • Laure Benoît,
  • Margot Ambille,
  • Paul Berveiller,
  • Isabelle Enderle,
  • Maëla Le Lous,
  • Mary Pontvianne,
  • Paul Guerby,
  • Christophe Vayssiere,
  • Franck Perrotin,
  • Gilles Kayem,
  • Jeanne Sibiude,
  • Elie Azria,
  • Marie Houllier,
  • Dominique Luton,
  • Thomas Schmitz,
  • Diane Korb,
  • Bassam Haddad,
  • Edouard Lecarpentier,
  • Oana-Alexandra Popa-Bobescu,
  • Xavier Fritel,
  • Charles Garabedian,
  • Emmanuel Simon,
  • Julie Blanc,
  • Hélène Heckenroth,
  • Florence Bretelle,
  • Nicolas Sananès,
  • Louise Maretti Reheis,
  • Alexandra Benachi,
  • Alexandre Vivanti,
  • Laurent Mandelbrot,
  • Didier Riethmuller,
  • Franck Mauviel,
  • Vincent Dochez,
  • Mireille Ruiz,
  • Bénédicte Paindaveine,
  • Tiphaine Barjat,
  • Charline Bertholdt,
  • Céline Chauleur,
  • Catherine Deneux-Tharaux,
  • Pierre Delorme,
  • Philippe Deruelle,
  • Caroline Diguisto,
  • Muriel Doret,
  • Anne Ego,
  • Charles Garabédian,
  • Aude Girault,
  • Cyril Huissoud,
  • Lola Loussert,
  • Patrick Rozenberg,
  • Marie-Victoire Senat,
  • Eric Verspyck,
  • Norbert Winer

摘要

Background

The ARRIVE trial showed that elective induction of labor at 39 weeks for low-risk nulliparous women compared to expectant management reduced cesarean delivery rates with a nonsignificant trend toward decreased perinatal morbidity. However, the generalizability of these findings to other health care systems and obstetric contexts outside of the United States remains uncertain.

Methods

The FRENCH-ARRIVE multicenter, randomized controlled trial with two parallel groups, modeled on the ARRIVE trial, will include 4200 low-risk nulliparous women with singleton pregnancies from 37 weeks 0 days through 38 weeks 6 days of gestation. Women will be randomized in a 1:1 ratio to either elective induction between 39 weeks 0 days and 39 weeks 4 days of gestation or expectant management. The primary outcome will be the incidence of cesarean deliveries after randomization, regardless of indication. This study will have a power of 80% to show a 20% reduction in the cesarean incidence from 15.0% to 12.0%. Secondary outcomes will include indicators of maternal and perinatal morbidity and of health-care resource utilization, defined consistently with those of the ARRIVE trial to allow meaningful comparisons.

Discussion

This large, multicenter, randomized controlled trial, as the first replication of the ARRIVE trial in a different setting, aims to compare the effect of elective induction of labor at 39 weeks of gestation versus expectant management on the incidence of cesarean delivery in low-risk nulliparous women.

Trial registration

ClinicalTrials.gov NCT04799912 (March 12, 2021).