Blind Spots by Marty Makary

Author:Marty Makary
Language: eng
Format: epub
Publisher: Bloomsbury Publishing

Does Every Woman Need to Be Induced?

“There’s one more thing you should look at,” Dr. Hansen Lindner told me as we started to wrap up our meeting. “You should have your research team at Hopkins take a look at the ARRIVE trial.”

Ah yes, I recalled the ARRIVE trial. The landmark 2018 study counterintuitively made inducing labor a new standard of care for nearly every low-risk pregnancy, as opposed to using it on occasion, only when deemed necessary.35

The study enrolled approximately 6,000 women with low-risk pregnancies and randomized them when they got to 38 weeks. Half were given a drug like Pitocin to induce labor at 39 weeks, and the other half were treated “expectantly,” that is, doctors waited for the woman to go into labor on her own (with some exceptions), as doctors had been doing for centuries. The study, published in the New England Journal, claimed that the routine induction of labor group suffered fewer complications. But oddly, the study made its claim of superiority by adding unrelated outcomes together—outcomes that were not statistically significant by themselves. They also skewed their results by bizarrely allowing expectant mothers to progress far longer in their pregnancy than most obstetricians would feel comfortable because of the known harms of delivering after 42 weeks. The study design seemed stacked against waiting for labor to occur naturally.

I printed out the study and handed it to our research team to examine its methodology. The two statisticians at the meeting quickly pointed out the same problem: grouping compilations into “bundles.” Grouping rare events is a well-known way to “massage the results,” to take a study that does not show a statistically significant difference and make it show one. Our research team concluded that the study had major limitations, some of which the authors even acknowledged in their article. The team felt that the New England Journal should have rejected the study.

Despite the study’s design flaws, it changed practices in America. Beginning in 2018, some hospitals instituted routine induction for all low-risk women at 39 weeks, in part because of the ARRIVE trial. Dr. Hansen Lindner and many other doctors, however, have not changed the way they practice.

A subsequent study published in 2023 pointed out that since the publication of the ARRIVE trial, the number of inductions had gone up, but with no reduction in complication rates, countering the predictions of the ARRIVE authors.36 If a repeat study contradicts the ARRIVE study, it would not be the first time that a current practice based on a New England Journal study got reversed. For most of the last two decades, the drug Makena was hailed as the first medication that could prevent preterm labor, which leads to premature newborns. For centuries, nothing has worked to stop this problem. The drug received an accelerated FDA approval in 2011 based on a New England Journal study37 and was given to more than a quarter million women, many of them poor and on Medicaid. But then scientists at the FDA pointed

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