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ACNM Responds to Release of ARRIVE Trial Study Results: Acknowledges Quality of Study but Raises Concerns about Potential for Misapplying Results

FOR IMMEDIATE RELEASE: Thursday, August 9, 2018

The American College of Nurse-Midwives Affirms Its Support of Normal Physiologic Birth, Shared Decision Making, and Individual Autonomy

Silver Spring, MD -- The American College of Nurse-Midwives (ACNM) affirms its support for the promotion of normal healthy physiologic birth and a women's right to self-determination as we acknowledge the publication of the ARRIVE trial results in "Labor Induction verses Expectant Management in Low-Risk Nulliparous Women" in the New England Journal of Medicine on August 8, 2018.  The ARRIVE trial was a randomized controlled clinical study that compared elective induction of labor at 39 weeks to expectant management of labor with women who were nulliparous and met study criteria to be identified as low risk. The primary outcome assessed by the trial was a composite measure of perinatal mortality and severe perinatal morbidity. This outcome was not statistically significant between the groups. A secondary outcome, however, was focused on the role of elective induction of labor and risk for primary cesarean birth. The results of the trial suggest that elective induction of labor in women with low-risk pregnancies at 39 weeks may reduce the need for cesarean delivery compared to waiting for spontaneous labor to occur. The difference in the reduction of cesarean birth was 18.6% in the induced group versus 22.2% in the expectant labor management group (P=<0.001).

We acknowledge the quality of the study design and the comprehensive areas of assessment that were included in the ARRIVE trial. We note that of the 22,533 women eligible to participate in this study, only 27% (6,106) actually agreed to participate. This demonstrates that the process of an elective induction of labor is not something women may choose or desire. 

ACNM President Dr. Susan Stone, DNSc, CNM, FACNM, FAAN raises concern about the costs to our society of adopting the use of elective inductions of labor given hospital stays, staffing resources, and capacity of our maternity care system. Information about these costs is not yet available, but is forthcoming. "Could those costs be put to a better use adopting a more non-interventive, low-cost strategy for reducing cesarean sections?" she asked. "There are many other evidence-based approaches to reducing primary cesarean birth that can also be adopted, such as continuity of care during labor."  For example, a recent Cochrane Database Systematic Review reported that if 14 women have continuous labor support, one cesarean birth can be prevented (Bohren MA, Hofmeyr  GJ, Sakala  C, Fukuzawa  RK, Cuthbert, 2017). The ARRIVE trial reported that 28 women will have to undergo an elective induction to prevent a single cesarean birth.

The selection criteria used for the women who participated in the trial are not generalizable beyond this particular group. Thus, the results should not be applied outside of the criteria used in the trial including women who are healthy, low risk, and experiencing their first birth. 

We are concerned that these study results have a high potential to be applied in ways that are not consistent with the parameters of the ARRIVE trial, which can result in unintended consequences.  While we strongly support measures to reduce the incidence of primary cesarean births for women in this country, we note that the cesarean section rates cited in the ARRIVE trial are below the national average goal of 23.9% for primary cesareans nationally. This may be attributed to the approach to care during labor used during this trial, which included adoption of the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) recommendations for extended time when an induction of labor is performed. Without this protocol, the results may have been different, and this will need to be emphasized in any recommendations for induction of labor aligned with these study results.

The American College of Nurse-Midwives strongly endorses the need for shared decision-making and equitable access to evidence-based information to use in discussions between childbearing families and their health care providers "We urge health care providers to be responsible, accurate, and cautious in their messaging to childbearing families about the use of elective induction of labor as an intervention to reduce the risk of cesarean delivery," Dr. Stone said. "There are a number of implications for childbearing women. We will closely monitor the additional outcomes of this study to more fully consider the impact of elective induction compared to spontaneous labor and expectant management on other health outcomes for mothers and infants."  

ACNM has a number of resources available for health care providers and consumers at
www.BirthTOOLS.org that support changing the culture of maternity care and optimizing health outcomes for families. ACNM has noted there are a number of potentially negative implications when we disrupt the normal physiological processes of labor and birth. Research related to the longer-term effects of induction of labor is emerging, but is still insufficient to determine its full impact.

ACNM continues to
stand by its current recommendations and encourages its members and other providers to refer to its formal position statements for guidance, including  the Consensus Statement on Supporting Healthy and Normal Physiologic Childbirth, Shared Decision Making in Midwifery Care, and Appropriate Use of Technology In Childbirth. We plan to review our current statement on Induction of Labor to include the ARRIVE trial results and assess the need for more specific practice recommendations very soon. 

Susan Stone, DNSc, CNM, FACNM, FAAN,
President, American College of Nurse-Midwives

Bohren MA, Hofmeyr  GJ, Sakala  C, Fukuzawa  RK, Cuthbert  A. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews 2017, Issue 7. Art. No.: CD003766. DOI: 10.1002/14651858.CD003766.pub6.

About ACNM

With nearly 7000 members, ACNM is the professional association that represents certified nurse-midwives (CNMs) and certified midwives (CMs) in the United States. ACNM promotes excellence in midwifery education, clinical practice, and research. With roots dating to 1929, our members are primary care providers for women throughout the lifespan, with a special emphasis on pregnancy, childbirth, and gynecologic and reproductive health. ACNM provides research, administers and promotes continuing education programs, establishes clinical practice standards, and creates liaisons with state and federal agencies and members of Congress to increase the visibility and recognition of midwifery care.

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