Significant Adverse Events and Outcomes After Medical... : Obstetrics & Gynecology (original) (raw)

Original Research

Cleland, Kelly MPA, MPH; Creinin, Mitchell D. MD; Nucatola, Deborah MD; Nshom, Montsine MPH; Trussell, James PhD

Office of Population Research, Princeton University, Princeton, New Jersey; the Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, California; Planned Parenthood Federation of America, New York, New York; and The Hull York Medical School, University of Hull, Hull, United Kingdom.

Corresponding author: Kelly Cleland, MPA, MPH, 218 Wallace Hall, Princeton University, Princeton, NJ 08648; e-mail: [email protected].

Supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development grant for Infrastructure for Population Research at Princeton University, grant R24HD047879 (J.T.).

The authors thank Mimi Tannen, NP, and Elizabeth Talmont, MSN, NP, of the Planned Parenthood Federation of America (PPFA) for their work related to the medical abortion adverse event reporting system and database.

Financial Disclosure Dr. Creinin receives compensation from Danco Laboratories, LLC, the distributor of mifepristone in the United States, for providing third-party telephone consults to clinicians who call for expert advice on mifepristone. The other authors did not report any potential conflicts of interest.

OBJECTIVE:

To analyze rates of significant adverse events and outcomes in women having a medical abortion at Planned Parenthood health centers in 2009 and 2010 and to identify changes in the rates of adverse events and outcomes between the 2 years.

METHODS:

In this database review we analyzed data from Planned Parenthood affiliates that provided medical abortion in 2009 and 2010 almost exclusively using an evidence-based buccal misoprostol regimen. We evaluated the incidence of six clinically significant adverse events (hospital admission, blood transfusion, emergency department treatment, intravenous antibiotics administration, infection, and death) and two significant outcomes (ongoing pregnancy and ectopic pregnancy diagnosed after medical abortion treatment was initiated). We calculated an overall rate as well as rates for each event and identified changes between the 2 years.

RESULTS:

Among 233,805 medical abortions provided in 2009 and 2010, significant adverse events or outcomes were reported in 1,530 cases (0.65%). There was no statistically significant difference in overall rates between years. The most common significant outcome was ongoing intrauterine pregnancy (0.50%); significant adverse events occurred in 0.16% of cases. One patient death occurred as a result of an undiagnosed ectopic pregnancy. Only rates for emergency department treatment and blood transfusion differed by year and were slightly higher in 2010.

CONCLUSION:

Review of this large data set reinforces the safety of the evidence-based medical abortion regimen.

LEVEL OF EVIDENCE:

III