New Research on Labor Induction Creates Controversy
February 5, 2018
By Jill Arnold
Dr. William Grobman presents research findings of the ARRIVE trial at the SMFM 38th Annual Pregnancy Meeting in Dallas, Texas, on February 1, 2018.
New research findings were presented last week at Society for Maternal Fetal Medicine’s 38th Annual Pregnancy Meeting in Dallas, Texas, that showed that inducing labor in healthy patients after 39 weeks of pregnancy might lower their need for a cesarean birth. The study authors also observed lower rates of preeclampsia and gestational hypertension in the elective induction group.
The multi-center study of 6,106 women, also called the ARRIVE trial, took place from March 2014 to August 2017 at 41 hospitals throughout the United States and news of the findings has generated controversy on various social media sites.
Commenters on Society for Maternal Fetal Medicine’s Facebook page expressed concerns such as, “You've got to be sh*tting me… who 'sponsored' this study?” and “Let’s fix one iatrogenic problem with another.” Some Twitter users questioned the study design itself. Activist and March for Moms board member Dawn Thompson posted concerns on Facebook that articles about the study will result in women consenting to induction.
SMFM responded to concerns and inquiries on their page by explaining that their current guidelines do not recommend routine induction of labor for low-risk pregnant women at 39 weeks of gestation and that the ARRIVE trial has not been published in a peer-reviewed publication.
Dr. Neel Shah, Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, called the science "sound" in a thread on Twitter but expressed concerns about how the results might be interpreted.
1/ This will make national headlines tomorrow. Many will not like it. The debate should not be about the science (which is sound) but about what to do with the result.
— Neel Shah, MD (@neel_shah) February 1, 2018
Needs more nuanced interpretation than "inducing labor for all women at 39 weeks decreases c-section rates" https://t.co/I6BDR9qnjO
I spoke briefly with Dr. Grobman about some of the public's questions online about the ARRIVE trial's design.
How did you and your colleagues choose this particular study design?
Grobman: There are two pieces to that answer. One is that we chose a randomized trial because a randomized trial is the type of study that lowers the chance that other things unrelated to the intervention are affecting the outcomes that are being studied. The other reason for the study design is that it very specifically compares induction to the alternative to induction, which is expectant management, not spontaneous labor because spontaneous labor is not inevitably going to occur. [Note: Dr. Grobman further explained that in some cases labor won’t start on its own because some women might end up undergoing induction if a medical indication arises.]
It appears that there are questions on social media about the randomization process itself. Are there ethical issues surrounding the inclusion of pregnant people in randomized control trials in general?
Grobman: It’s completely ethical to offer a randomized trial to pregnant women. When you don’t know whether an intervention is harmful or helpful, the only ethical thing to do is to evaluate it so that you know when you offer it—or don’t offer it—to people, you’re doing something that gives them the best chance of a [good] outcome.
I would say it would be unethical to exclude pregnant women from randomized trials because that would mean that they are systematically receiving subpar care compared to everyone else. This is because we’re aspiring to give to everyone only the interventions that provide some benefit. If we suddenly didn’t apply those same standards to pregnant women, they would be basically receiving care only based on what we judge to be good or bad based on our own anecdotal experience.
What do you see coming next?
Grobman: I think it’s always important for this or any study to await peer review so that methods can be evaluated completely by professional colleagues and organizations.
Society for Maternal Fetal Medicine's press release on the ARRIVE trial states that nothing would change as a result of the study until further analysis is undertaken.
SMFM’s current guidelines do not recommend routine induction of labor for low-risk pregnant women at 39 weeks of gestation. “SMFM will wait to evaluate the peer-reviewed publication of the ARRIVE Trial before providing any guidance or changes to our existing recommendations,” said Alfred Abuhamad, MD, the President of SMFM.
The National Accreta Foundation is non-profit organization whose mission is eliminating preventable maternal mortality and severe maternal morbidity attributable to placenta accreta. Learn more about NAF's mission and programs.