California is about to embark on a bold experiment to lower the C-section rate. People may get hurt.

Doctor holding new born

California is about to experiment on its mothers and babies.

Ordinarily we would look with horror on a state’s desire to experiment on its own people. Yet when the purported justification is preventive care, we suspend our distaste under the theory that preventive care is always a good thing; as a result people get hurt or even die. Sadly, we have not yet learned our lesson from other preventive care debacles like those with hormone replacement therapy (HRT) and the PSA test.

According to NPR:

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Its proponents are sure that it will lead to improved outcomes and money saved; the proponents of routine HRT, routine PSA testing, and the 39 week rule were also sure. They were wrong.[/pullquote]

Many women who don’t need a C-section often get one anyway, according to the data — and it varies from hospital to hospital. Even for low-risk cases, Lang says, several California hospitals are delivering 40 percent of babies by C-section. At one hospital, it’s 78 percent…

… Performing it when it’s not needed exposes a woman to unnecessary risks: infection, hemorrhage, even death.

Studies also have found that babies delivered by C-section are more likely to have complications and spend more time in the neonatal intensive care unit.

That’s not quality health care, Lang says, and that’s why Covered California is telling hospitals they need to reduce their C-section rates to 23.9 percent or lower, for low-risk births.

What will happen if they don’t?

Starting in less than two years, if the hospitals haven’t met certain designated targets for safety and quality, they’ll risk being excluded from the “in-network” designation of health plans sold on the state’s insurance exchange…

… Covered California is telling hospitals that if don’t play by the rules, they’ll be benched

Surely a massive experiment like this is based on solid data that definitively shows two things: that lower C-section rates cause better outcomes and that blunt efforts to lower C-section rates don’t lead to increased deaths and injuries. Nope. It’s based entirely on studies that show a correlation of lower C-section rates with acceptable outcomes in some settings. To my knowledge, there are no large scale studies of what happens when insurers pressure hospitals to lower C-section rates.

We’ve been here before — many times.

When I finished my residency 30 years ago, it was standard of care to prescribe hormone replacement therapy for all post-menopausal women. Many physicians were well aware at the time that the data showed only a correlation between HRT and lower mortality from heart disease. We were equally aware that there was no data to tell us what the side effects of years of HRT might be.

No matter. We were told that HRT would lead to better fewer cardiac deaths and would surely save money. Sadly, the exact opposite happened. HRT did not cause fewer cardiac deaths (no money saved there) and actually increased the rate of breast cancer (a very expensive side effect).

A similar debacle occured with PSA (prostate specific antigen) testing. Since increased PSA is associated with prostate cancer, doctors began recommending routine PSA screening, despite the fact that there were no large scale, long term studies demonstrating benefit. It was preventive medicine; so surely it would cause better outcomes and save money. Wrong again.

According to the National Cancer Institute:

Until about 2008, some doctors and professional organizations encouraged yearly PSA screening for men beginning at age 50. Some organizations recommended that men who are at higher risk of prostate cancer, including African American men and men whose father or brother had prostate cancer, begin screening at age 40 or 45. However, as more was learned about both the benefits and harms of prostate cancer screening, a number of organizations began to caution against routine population screening…

It turned out that many prostate cancers did not grow fast enough to threaten a man’s life. Removing such cancers led to the dreaded side effects treatment: incontinence and erectile dysfunction without saving any lives. It didn’t save money, either.

In order to lower the induction rate we are currently engaged in an experiment on mothers and babies. The 39 weeks rule (no elective inductions before 39 weeks) has been enforced for several years. It was promised that it would lead to a lower neonatal mortality from late prematurity, though many obstetricians suspected that it would actually lead to higher stillbirth rates. The preliminary data was not encouraging.

Changes in the patterns and rates of term stillbirth in the USA following the adoption of the 39-week rule: a cause for concern? was presented at the 2016 annual meeting of the Society for Maternal-Fetal Medicine.

Between 2007 and 2013 in the USA, the implementation of the 39-week rule achieved its primary goal of reducing the proportion of term births occurring before the 39th week of gestation. During the same period the rate of USA term stillbirth increased significantly. Assuming 3.5 million term USA births per year, more than 300 more term stillbirths occurred in the USA in 2013 as compared to 2007…

A new, large study, Association of Temporal Changes in Gestational Age With Perinatal Mortality in the United States, 2007-2015, shows that the 39 week rule has changed the distribution of gestation age at birth — reducing births at 37-38 weeks and increasing births at 39 weeks — but has NOT had the promised impact on death rates.

I graphed the change in gestational age distribution:


What happened to infant deaths?

The overall perinatal mortality rate decreased from 9.0 per 1000 births in 2007 to 8.6 per 1000 births in 2015 (P < .001).

Perinatal mortality decreased at gestational ages of 20 to 27 and 39 to 40 weeks but showed annual adjusted relative increases of 1.0% (95% CI, 0.6%-1.4%) at 34 to 36 weeks, 2.3% (95% CI, 1.9%-2.8%) at 37 to 38 weeks, and 4.2% (95% CI, 1.5%-7.0%) at 42 to 44 weeks.

Stillbirth rates increased at gestational ages of 20 to 27, 28 to 31, 32 to 33, 34 to 36, 37 to 38, and 42 to 44 weeks and remained unchanged at 41 weeks. Neonatal mortality rates decreased at gestational ages of 20 to 27 and 28 to 31 weeks; increased at 34 to 36, 37 to 38, and 42 to 44 weeks; and remained unchanged at 41 weeks.

That’s almost exactly the opposite of what was predicted. Neonatal mortality at 34-36 weeks and 37-38 weeks did NOT drop; it actually INCREASED. Moreover, stillbirths INCREASED, too.

Why did the overall perinatal mortality rate drop? NOT because of the 39 week rule, but because of improvements in the care of extremely premature infants (21-27 weeks).

What went wrong? Once again correlation was confused for causation and a measure designed to save lives at 34-38 weeks actually led to increased deaths.

And now we’re about to embark on a similar experiment to lower C-section rates.

So far, the prospect of exclusion, plus the coaching for hospitals on how to reduce the rates, have functioned as an effective motivator.

By 2020, Covered California’s Lang believes all hospitals will either have met the target or be on their way.

“It’s a quality improvement project,” Lang says, “but with a deadline.”

Its proponents are sure that it will lead to improved outcomes and money saved … exactly the proponents of routine HRT, routine PSA testing, and implementation of the 39 week rules were sure that those were quality improvements. They were wrong.

California is embarking on a massive experiment on mothers and babies. Let’s hope they don’t inadvertently injure and kill them as a result.