A recent study published in JAMA Network Open has revealed that mifepristone, a medication used in the management of early pregnancy loss (EPL), is significantly underutilized. EPL is the most common complication of early pregnancy, affecting over 1 million individuals in the United States annually.
When it comes to managing EPL, there are three main treatment options: medication management, expectant management, and procedural management. Each of these approaches has demonstrated efficacy in hemodynamically stable patients. However, only about 10% of these individuals opt for medication management in the U.S., which typically involves administering misoprostol with or without mifepristone.
Studies indicate that using mifepristone in combination with misoprostol enhances efficacy compared to misoprostol alone. Consequently, the American College of Obstetricians and Gynecologists recommended this combination therapy in their 2018 guidelines. Despite this recommendation, the use of mifepristone for EPL management remains low.
To assess the differences in clinical outcomes associated with mifepristone plus misoprostol versus misoprostol alone, researchers conducted a retrospective cohort study. They analyzed data from U.S. patients with EPL between October 1, 2015, and December 31, 2022, sourced from the IBM MarketScan Research Database.
Key data collected included service dates and locations, demographic characteristics, diagnosis and procedure codes, and medication prescriptions. Patients with ectopic or molar pregnancies, induced abortions, stillbirths, or those who had received recent EPL management were excluded from the analysis.
The primary exposure under examination was the use of mifepristone alongside misoprostol compared to the use of misoprostol alone. Covariates included patient age, encounter years, geographic region, metropolitan statistical area status, location of service, and insurance policy status.
The study comprised 31,977 individuals, with a mean age of 32.7 years, who received medication management following an EPL diagnosis. The rate of mifepristone use in conjunction with misoprostol rose from 0.7% in 2015 to 8.6% in 2022. Notably, mifepristone was more commonly utilized among older patients, those in urban settings, and residents of the Northeast and West.
Of the participants, 72.3% had experienced a missed abortion, while 26.9% had a spontaneous abortion, and 0.8% experienced both. Mifepristone was used by 3.3% of patients with missed abortion and 2.5% with spontaneous abortion.
Most patients received their initial EPL diagnosis in an outpatient setting, where mifepristone was more prevalent than in emergency department or other settings. Procedural management rates were higher for those using misoprostol alone compared to those using both mifepristone and misoprostol, with rates of 14% and 10.5%, respectively.
Moreover, the odds of requiring additional EPL-related care were 7.1% for patients using misoprostol only in an outpatient setting, compared to just 3.1% for those using mifepristone. Complication rates were low in both groups, with 0.9% for the misoprostol-only group and 0.4% for the mifepristone plus misoprostol group.
The study reported an adjusted odds ratio (AOR) of 0.71 for the need for subsequent procedural management following mifepristone use, indicating a decreased risk compared to those who used misoprostol alone. Factors such as an initial visit to the emergency department and being a dependent policyholder were also associated with reduced risks, with AORs of 0.62 and 0.81, respectively.
The findings highlight the underutilization of mifepristone in managing EPL, despite evidence suggesting it lowers the odds of requiring additional care. The researchers concluded that further efforts are necessary to address barriers to mifepristone use, ensuring that patients have access to effective medication management options for early pregnancy loss.
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