ARRIVE Trial: Talking Points for Members
There have been numerous studies demonstrating a correlation between elective induction of labor, adverse maternal outcomes, and cesarean birth. The ARRIVE Trial, recently published in the New England Journal of Medicine, was initiated in response to concerns raised regarding the risks and benefits of elective induction of labor. Prior studies used designs such as observational cohorts and comparisons of labor induction to spontaneous labor onset, instead of comparing the perinatal outcomes of women who had labor induction to women who were managed expectantly. This trial was designed to answer questions about whether elective induction of labor at 39 weeks was associated with a lower risk of perinatal death or severe neonatal complications than expectant management.
The low-risk, nulliparous women who participated in this study had reliable estimated due dates and carried a live, singleton fetus in vertex presentation. The study recruited women who were planning to give birth in one of 41 large hospitals that participate in the Maternal-Fetal Medicine Network Unit. Although there were 22,533 women eligible for this study, only 27% (6106) agreed to participate, which can signal that the study sample may be different from the target population.
The women were randomized to induction of labor at 39 weeks versus expectant management. Of those 6106 randomized, 5772 (94.5%) delivered within the research guidelines. These guidelines included women in the induction group undergoing induction at 39 0/7-39 4/7 weeks. Women participating within the expectant management group were not induced until at least 40 5/7-42 2/7 weeks, unless they had a medical indication.
The median gestational age at birth was 4 days shorter (39.3 weeks) for the induction group when compared with the expectant management group (40 weeks), a difference of only 4 days. The median maternal age for the induction group was 24 years, and the median maternal age for the expectant management group was 23 years. Of note--the mean maternal age in the United States was 26.6 years in 2016, so the women in this study were slightly younger than the general population of women giving birth today. (https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_01.pdf) The study publication did not include mean age for comparison to the US mean age.
There were several outcomes reported from this study. These include the following:
Here are some additional details to be aware of regarding the ARRIVE Trial:
When interpreting the results of the ARRIVE trial, caution is necessary. Based upon selection criteria for the trial, these results are not generalizable to all low-risk women at term. For example:
For the reasons outlined above, the results of the ARRIVE trial will not be applicable to all women at 39 weeks gestation. These participants were low-risk, nulliparous young women with reliable EDCs experiencing uncomplicated pregnancies. Misinterpretation and incorrect application of the ARRIVE Trial findings could have unintended adverse consequences for women who do not have the same demographic or obstetric characteristics.
Implementation of practice changes to offer 39 week induction of labor should proceed cautiously after thoughtful consideration of available research and not based solely on the findings of one study. All decisions regarding maternity care should incorporate the woman’s personal preferences and medical needs as paramount. Research related to the longer-term effects of induction of labor is still insufficient to determine its full impact.
ACNM is committed to supporting informed decisions regarding maternity care and safeguarding women’s opportunity to have a healthy physiologic birth and avoiding unnecessary procedures (http://www.midwife.org/acnm-healthy-birth-initiative). We have several robust programs available to decrease the risk of cesarean birth including www.birthtools.org and www.birthtools.org/HBI-Reducing-Primary-Cesareans, and are committed to supporting woman-centered, evidence-based maternity care.
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