Did a law regulating drug-induced abortions keep women safe or block them from access to this procedure?

A study published Tuesday in the journal PLOS Medicine suggests an Ohio law limiting how women can obtain medical abortions may have led to a higher rate of complications. But the law’s defenders said these conclusions should be viewed with skepticism, and that researchers detected more need for follow-up care because the law resulted in more careful patient monitoring, unearthing problems they say were already there.

The findings add to the ongoing national debate over abortion, and whether and how to regulate it.

The study, conducted by researchers from the University of California, San Francisco, analyzed the now five-year-old law. Similar measures are on the books in Texas and North Dakota.

Ohio’s law requires that women receiving a so-called “medication abortion” take the pills in accordance with Food and Drug Administration protocols, which were put in place when the procedure was approved in 2000.

Here is how it works: Women in the early stages of pregnancy take a two-pill regimen — mifepristone and then, a day or two later, misoprostol — to induce abortion. It typically causes some level of cramping and bleeding. Both dosage amounts were set by the agency and had to be taken at a doctor’s office before the pregnancy reached seven weeks.

Research in the ensuing years suggested smaller doses of the pills are equally effective, and that women can take the misoprostol dose at home, on their own. That brings down the number of needed doctor’s visits to the initial mifepristone trip and a follow-up after, to verify the abortion in fact took place. In response, many physicians in states without such statutory requirements prescribed an “off-label” form of the treatment, rather than the one that had been sanctioned by the FDA or by the Ohio law.

The FDA updated its original medication abortion protocols in March. So, the Ohio law, which says doctors must adhere to the agency’s rules, now aligns with this revamped regimen, meaning women only have to see a doctor twice, can take smaller doses and have 10 weeks to get a medication abortion.

This reflects a concern many doctors had put forth: that tying the law to this 16-year-old standard of care placed an undue burden on women, requiring them to visit the doctor more often, take larger doses and get the procedure done earlier in their pregnancy — within seven weeks. That, they said, could have a chilling effect, especially as those laws were often passed in tandem with other restrictions, like requiring hospital admitting privileges for the doctors performing abortions, and having facilities providing them meet certain building standards.

But the new alignment between the FDA and best practice is not necessarily permanent, so laws like Ohio’s still raise a red flag, said Ushma Upadhyay, an associate professor of obstetrics, gynecology and reproductive health at UCSF, and the study’s lead author. As science progresses, researchers and health professionals may discover more effective or more convenient ways to administer medication abortion. For instance, clinical trials are underway to expand the timeframe in which the procedure is safe. Because medical best practices change more quickly than FDA approval, she added, women who live where these laws are still on the books could, in the future, face a similar gulf between the best care option and what, under the law, doctors are allowed to do.

“There’s an increasing number of restrictions on all abortions, including medication abortion,” Upadhyay said. “Often they’re under the guise of improving health and safety for women. And what is needed is more evidence.”

In this study, researchers used information from four major abortion providers in Ohio to examine medication abortions, looking at about 1,200 cases before the law and nearly 1,600 after.

Their findings: Once the law was in effect, women were three times as likely to need extra medical care after the procedure, such as follow-up visits or more medication. Women more frequently experienced side effects like nausea and vomiting. They faced higher costs — likely, the researchers said, because they had to take larger amounts of medication. A standard medication abortion can cost between $300 and $800. In addition, they were far less likely to seek out the medication abortion option. The incidence rate for this procedure dropped from 22 percent of women in 2010 to about 5 percent in 2014, a dip the study authors attributed to greater difficulty in paying or meeting the requirements for a medication abortion.

“Between the cost, and the extra trips and the shorter time period, it didn’t make it feasible” to have a medication abortion, said Heather Boonstra, director of public policy for the Guttmacher Institute, which researches reproductive issues. That, she added, put states with these restrictions out of step with women’s preferences.

“Observationally, what you see across the nation over time is an increased use of mediation abortion,” said Boonstra, who did not help with the study. “That trend continued in other parts of the nation, whereas you saw this significant drop in Ohio.”

The researchers also note that those consequences do not appear uniformly distributed. Women covered by Medicaid, the federal-state insurance plan for low-income people, were less likely to receive follow-up care than their privately-insured counterparts. It is unclear why that was the case, Upadhyay said, but it is possible those women needed follow-up treatment and were not able to get it, thanks to barriers like needing childcare, working multiple jobs or not being able to find transportation to the clinic.

Americans United for Life, an anti-abortion advocacy group that has presented evidence in support of laws such as Ohio’s medication abortion measure, dismissed the research as biased. “When considering a study, you have to consider the source,” said Clarke Forsythe, the group’s acting president and senior counsel, in a statement.

AUL is reviewing potential legislation to push next year, said Kristi Hamrick, an organization spokeswoman, and medication abortion will likely remain a subject of conversation, she said, adding that the organization is concerned about the drug’s potential consequences. “I suspect we will be talking about this for a while,” Hamrick said.

However, research has found that, while medication abortion is somewhat riskier than its surgical counterpart, complications are very rare.

While women needed extra medical care, it is not clear the abortion laws put them at risk, Upadhyay noted. Most got an extra dose of medication, or had the abortion performed through the more common, invasive procedure, she said. But the abortion process as a whole was “a lot more burdensome” without needing to be, she said. And the increased requirements for getting the procedure meant women faced more barriers toward getting health care generally.

Updated, August 30, 9:45 PM to include the correct title in which the study appeared.