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Medication abortion had high rates of safety and efficacy among patients who were screened by their medical history alone, according to a retrospective cohort study.

Among a group of nearly 4,000 patients who did not undergo an ultrasound or pelvic exam prior to taking mifepristone (Mifeprex) and misoprostol (Cytotec), abortion occurred for 94.8% (95% CI 93.6-95.9%), reported Ushma D. Upadhyay, PhD, MPH, of the University of California in San Francisco, and colleagues.

Effectiveness of medication abortion was not significantly different between patients who picked up their medication in person and those who received them by mail (95.4% vs 93.3%, respectively), the researchers wrote in .

Overall, 12 patients -- approximately 0.5% of the sample -- had a major abortion-related adverse event, and four were treated for ectopic pregnancies. Major abortion-related adverse events were also not significantly different between patients who picked up the medications in person versus by mail (0.46%, vs 0.76%, respectively).

Given the high effectiveness and low risk of omitting in-person tests, the study authors stated, "no-test medication abortion can offer substantial benefits to clinicians and patients and is consistent with the principle of patient-centered care."

Additionally, they stated that history-based screening alone may increase the types of clinicians -- such as primary care doctors and nurse practitioners -- who can perform medication abortions. Increasing the types of providers and locations of services will create more equitable access to abortion, Upadhyay and colleagues added, specifically for marginalized racial and ethnic groups and low-income patients.

In an , Jennifer Karlin, MD, PhD, of the University of California Davis, and Jamila Perritt, MD, MPH, of Physicians for Reproductive Health, agreed that this research provides evidence of safe and effective pregnancy termination "without requiring an in-person clinical evaluation."

The FDA recently lifted restrictions on mifepristone, no longer requiring the drug to be dispensed in-person. However, Karlin and Perritt noted that there are still protocols in place requiring special certifications for patients, providers and pharmacies around provision of the medication -- none of which have clinical benefits, according to available data.

"Researchers, clinician providers of abortion services, and experts are leading the way toward a less burdensome, evidence-based model of medication abortion care delivery," Karlin and Perritt wrote. "Hopefully, regulators will also follow the evidence and prioritize our collective principles of quality health care delivery."

Medication abortion with mifepristone and misoprostol is approved by the FDA for use through 70 days (approximately 10 weeks) of pregnancy. While clinicians have typically performed ultrasounds or pelvic sonograms to ascertain the gestational age of a pregnancy, many suspended those procedures during the COVID-19 pandemic to limit patients' exposure to the virus, instead relying on their medical history.

By October 2020, organizations including the Society of Family Planning and the American College of Obstetricians and Gynecologists to support this no-test approach.

Upadhyay and colleagues analyzed the safety and efficacy of medication abortion among patients who did not have a preabortion ultrasound or pelvic exam. Study participants underwent the procedure at one of 14 independent, Planned Parenthood, academic-affiliated, or online clinics in the U.S. between February 2020 and January 2021.

Abortions that were considered not complete included those in which the patient had an aspiration, dilation and evacuation, or any other surgical intervention, the patient received more than 200 mg of mifepristone, more than 1,600 μg of misoprostol, or other uterotonic medications, the patient received treatment for an ectopic pregnancy, or the patient had a viable pregnancy detected by ultrasound. Safety was defined as an abortion not followed by adverse events, including hospital admission, blood transfusion, major surgery, or death.

Upadhyay's group included 3,779 patients who had a medication abortion in the study cohort. In around 66% of the abortions, the medications were dispensed in person; the remaining 34% of patients received the pills in the mail. The study cohort comprised approximately 23% Black patients, 14% Latinx or Hispanic participants, 43% white patients, and 9% identified as multiracial. Half of the patients paid for their abortion out-of-pocket. Patients lived in 34 states, and nearly three-quarters were from urban areas.

Among approximately 2,800 patients with follow-up data, there were 12 major abortion-related adverse events, including eight blood transfusions, three major surgeries, and six hospital admissions. Overall, 72 patients visited emergency departments, which resulted in six admissions.

Nine patients had pregnancies that were greater than 70 days' gestation that were not identified at screening. Six of those patients had additional procedures to complete the abortion between 88 and 101 days' gestation, two patients had complete abortions without additional interventions at 16 and 33 weeks' gestation, and one who received mifepristone at 87 days' gestation had a continuing viable pregnancy.

Upadhyay and colleagues acknowledged that the retrospective design of their study limited the precision and detail of the data, as clinics did not have uniform criteria for assessing completion of abortion. Additionally, the study did not include a direct comparison group of patients who received preabortion ultrasonography or pelvic exams. The study authors also acknowledged that this research may have failed to detect some additional interventions and adverse events.

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