10.7272/0WEP-RZ15
Upadhyay, Ushma D.
Johns, Nicole E.
Combellick, Sarah L.
Kohn, Julia E.
Keder, Lisa M.
Roberts, Sarah C.M.
Comparison of Outcomes before and after Ohio's Law Mandating Use of
the FDAApproved Protocol for Medication Abortion: A Retrospective Cohort
Study
UC San Francisco
2016
Upadhyay, Ushma
2016-08-04T14:53:59+00:00
Dataset
http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002110
1432064
Creative Commons Attribution 4.0 International (CC BY 4.0)
Background: In February 2011, an Ohio law took effect mandating use of the
United States Food and Drug Administration (FDA)-approved protocol for
mifepristone, which is used with misoprostol for medication abortion.
Other state legislatures have passed or enacted similar laws requiring use
of the FDA-approved protocol for medication abortion. The objective of
this study is to examine the association of this legal change with
medication abortion outcomes and utilization.
Methods and Findings: We used a retrospective cohort design, comparing
outcomes of medication abortion patients in the prelaw period to those in
the postlaw period. Sociodemographic and clinical chart data were
abstracted from all medication abortion patients from 1 y prior to the
law’s implementation (January 2010–January 2011) to 3 y post
implementation (February 2011–October 2014) at four abortion-providing
health care facilities in Ohio. Outcome data were analyzed for all women
undergoing abortion at ≤49 d gestation during the study period. The main
outcomes were as follows: need for additional intervention following
medication abortion (such as aspiration, repeat misoprostol, and blood
transfusion), frequency of continuing pregnancy, reports of side effects,
and the proportion of abortions that were medication abortions (versus
other abortion procedures). Among the 2,783 medication abortions ≤49 d
gestation, 4.9% (95% CI: 3.7%–6.2%) in the prelaw and 14.3% (95% CI:
12.6%–16.0%) in the postlaw period required one or more additional
interventions. Women obtaining a medication abortion in the postlaw period
had three times the odds of requiring an additional intervention as women
in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI:
2.27–4.27). In a mixed effects multivariable model that uses
facility-months as the unit of analysis to account for lack of
independence by site, we found that the law change was associated with a
9.4% (95% CI: 4.0%–18.4%) absolute increase in the rate of requiring an
additional intervention. The most common subsequent intervention in both
periods was an additional misoprostol dose and was most commonly
administered to treat incomplete abortion. The percentage of women
requiring two or more follow-up visits increased from 4.2% (95% CI:
3.0%–5.3%) in the prelaw period to 6.2% (95% CI: 5.5%–8.0%) in the postlaw
period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6%
of women reported at least one side effect during their medication
abortion: 8.4% (95% CI: 6.8%–10.0%) in the prelaw period and 15.6% (95%
CI: 13.8%–17.3%) in the postlaw period (p < 0.001). Medication
abortions fell from 22% (95% CI: 20.8%–22.3%) of all abortions the year
before the law went into effect (2010) to 5% (95% CI: 4.8%–5.6%) 3 y after
(2014) (p < 0.001). The average patient charge increased from US$426 in
2010 to US$551 in 2014, representing a 16% increase after adjusting for
inflation in medical prices. The primary limitation to the study is that
it was a pre/post-observational study with no control group that was not
exposed to the law. Conclusions: Ohio law required use of a medication
abortion protocol that is associated with a greater need for additional
intervention, more visits, more side effects, and higher costs for women
relative to the evidence-based protocol. There is no evidence that the
change in law led to improved abortion outcomes. Indeed, our findings
suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio
providers may now legally provide current evidence-based protocols.
However, this law is still in place and bans physicians from using
mifepristone based on any new developments in clinical research as best
practices continue to be updated.