Neel Shah, Health-Care Innovator, Speaks Out on the ARRIVE Trial Examining 39-Week Inductions to Reduce Cesareans

arrive hero shah.jpgIt has been over a week since the release of the full ARRIVE Trial - Labor Induction versus Expectant Management in Low-Risk Nulliparous Women, and professionals are still working diligently to understand the results and determine what it means moving forward.  Henci Goer initially addressed the study abstract here and a few days ago examined the full study to share some takeaways.  In the meantime, I asked Neel Shah, MD, MMP, Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School and associate faculty at the Ariadne Labs for Health Systems Innovation for his thoughts on the ARRIVE Trial.  Dr. Shah is recognized as an innovative leader in maternal-infant health and a well-respected expert on effective methods for reducing the cesarean rate in the U.S.
Sharon Muza: I keep coming back to your statement, “too much, too soon, or too little, too late.”  Why do we have to “do something” that requires a large amount of financial and people resources instead of watchful waiting and expectant management?  Doesn’t it matter how we launch people into parenthood?  Exhausted after a long induction, questioning their body’s ability to birth physiologically on its own and emotionally fatigued from the huge amount of oversight during the induction process or strong and proud of what they just accomplished, when their body and their baby worked together (with or without an epidural, which is parent choice).  Why not intervene WHEN necessary, rather than as standard protocol? Aren’t there known suggestions for supporting physiological birth that improve outcomes (for example, Lamaze’s Six Healthy Birth Practices) and reduce cesareans and neonatal complications. Why this and why now?

Neel Shah: I think the ARRIVE trial was a very well conducted and necessary study that has been widely misunderstood. Before ARRIVE, it was widely believed that the decision to induce a woman after 39 weeks increases her risk of cesarean. The trial convincingly demonstrates is that this risk is not due to the DECISION to induce but rather HOW the induction is performed. This is a critically important distinction. If the goal is to reduce cesareans we should focus on how labor is managed, regardless of whether a woman is in spontaneous labor or undergoing induction. It does leave several other important questions unanswered: which inductions are truly necessary? How do we ensure clinicians and families are making informed, shared decisions? But these questions are outside the scope of the study itself.

To be clear: nobody is saying the EVERYONE should be induced. Any clinician who adopts that interpretation is not providing good care--period. 
neel shah arrive quote.jpgSM: The induction guidelines in the study demonstrated patience, time and a very controlled procedure for inducing. How likely is that protocol to be reliably replicated across the multitude of institutions that want to encourage the 39-week induction?  What happens when variables come into play in how the inductions are carried out which deviate from the trial?
NS: This is exactly my concern. Many factors limit the generalizability of this trial. Nearly 75% of eligible participants opt out, suggesting that those who enrolled were more motivated to undergo induction than most women (and that most women do not actually want to be induced). Moreover, the inductions take place in well-resourced tertiary medical centers with clinicians who know they are being studied, suggesting that these clinicians are both better positioned and more motivated than most to ensure a successful induction. 
If the trial was conducted with a different population and took place in community hospitals, it may very well have yielded a different result. 
SM: In your view, when students and clients bring up this information or share their health care provider’s recommendations to induce at 39 weeks based on this new research, how should childbirth educators, doulas, and other birth professionals be responding?  Should childbirth educators be proactively discussing this study in class when induction reasons are covered, so that families are prepared in case 39-week induction w/o medical indication is suggested for their own situation?
NS: Inductions of labor have an important role in caring for expecting families -- in my view, there are legitimate medical and nonmedical reasons to induce. The most important thing is that families are in the driver's seat and supported in making informed choices. 
In counseling families, it is important to emphasize that inductions require patience and are a very different experience than spontaneous labor...inductions involve medications, close monitoring, and often days in a hospital labor and delivery unit. 
Rushed inductions most likely do increase the cesarean rate. But the ARRIVE trial demonstrates that patient inductions coupled with sound care during labor do not. 


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