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.

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).