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    ARRIVE study: 39-week induction reduces frequency of cesarean in healthy women

    Results of a large randomized clinical trial presented at The Pregnancy Meeting indicate that in low-risk nulliparas, elective induction of labor (IOL) at 39 weeks lowers rates of cesarean delivery (CD) without significantly increasing adverse perinatal outcomes. The findings represent experience at 41 hospitals in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.   

    In the ARRIVE study, 61,06 low-risk nulliparas were randomized to either IOL or expectant management (EM) at 39 /07 to 39 4/7 weeks. A sample size of 6,000 was necessary to detect ≥ 40% difference in the primary perinatal outcome, assuming 85% power. Outcomes for the study were composite adverse perinatal events (primary) and CD (secondary). The perinatal events analyzed included perinatal death, respiratory support, Apgar score, hypoxic ischemic encephalopathy, and seizures. Besides CD, maternal outcomes studies included preeclampsia/gestational hypertension, chorioamnionitis, and third- and fourth-degree laceration.         

    At randomization, reliably determined gestational age ranged from 38 0/7 and 38 6/7 weeks.  All the women underwent cervical examination to determine modified Bishop score from 72 hours before to 24 hours after randomization. The women in the EM group were expected to forgo elective delivery before 40 5/7 weeks and to be delivered no later than 42 2/7 weeks. Of the women in the study, 94% in the IOL group and 95% in the EM group adhered to the study protocol.      

    Delivery in the IOL group was significantly earlier than in the EM group (39.3 weeks [IQR 39.1 to 39.6] vs 40.0 weeks [IQR 39.3 to 40.7]; P < .001). Preeclampsia and gestational hypertension occurred in 9% of the IOL group versus 14% of the EM group. Among newborns, 3% in the IOL group needed respiratory support versus 4% in the EM group. The primary (adverse) perinatal outcome occurred in 4.4% of the IOL group versus 5.4% of the EM group (RR 0.81, 95% CI 0.64 to 1.01; P = .06). Frequency of CD also was significantly lower in the IOL group (18.6% vs 22.2%; RR 0.84, 95% CI 0.76 to 0.93).

    The authors said that the findings for the primary and secondary outcome or CD were no different in subgroup analysis based on race/ethnicity, maternal age > 34 years, body mass index > 30 kg/m2 or modified Bishop score < 5.  They concluded that in low-risk nulliparas, IOL at 39 weeks reduces frequency of CD without statistically significantly changing frequency of a composite of adverse perinatal outcomes.   

    Reflecting on the study, Editorial Board member Sarah J. Kilpatrick, MD, PhD, said that “the results suggest that induction at 39 weeks in nulliparas may be beneficial, but these data are not yet published.” She noted that “important questions were raised at the meeting, including about the unusually low cesarean delivery rate and the lack of data on cost and length of stay.” Dr. Kilpatrick also cautioned that this report is based on data from an abstract data and not a final publication, which warrants caution before changing clinical management.   

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    Judith M. Orvos, ELS
    Judith M. Orvos, ELS, is a a BELS-certified medical writer and editor and an editorial consultant for Contemporary OB/GYN.
    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.


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