Nearly all medication abortions obtained via telehealth, whether via video or secure text messaging, were completed without further intervention and without adverse events, the prospective CHAT study found.
Among over 6,000 abortions, 97.7% (95% CI 97.2-98.1) were completed without further intervention, and the completion rate was similar for patients who had video calls (98.3%) or used text messaging (97.4%), reported Ushma Upadhyay, PhD, MPH, of the University of California San Francisco, and colleagues.
Less than 1% of patients had a serious abortion-related adverse event (0.25%) or were treated for an ectopic pregnancy (0.16%), and 1.3% of abortions were followed by emergency department visits, the authors wrote in .
Upadhyay told Ƶ that she has attempted to do this kind of research for years, but the FDA kept denying her applications -- until the Biden administration's takeover and subsequent lifting of the in-person dispensing requirement for mifepristone (Mifeprex).
"I think these results confirm that the FDA allowing removal of the in-person dispensing requirement was based in evidence and was an appropriate decision and should be allowed to stay," she said. Next month, the Supreme Court will weigh in on FDA v. Alliance for Hippocratic Medicine, which could result in the reinstating of the in-person dispensing requirement and the banning of prescription of the drug via telehealth.
"I think these [study] results also show that medication abortion care can be provided in a less medicalized way," Upadhyay noted, adding that there are still 11 states where abortion is legal but telehealth isn't. "I hope these results also impact state laws that currently prohibit telemedicine."
Ultimately, the authors concluded that their results "provide evidence that telehealth for abortion is effective and safe, with rates similar to in-person care," and that their findings "are reassuring as more clinicians begin to provide telehealth abortion care to patients in U.S. states with a ban, under the legal protections of their state's shield laws."
For this study, the team followed 6,034 patients from three large telemedicine clinics that operated in 20 states and Washington, D.C. from April 2021 to January 2022. These clinics offered medication abortion after the FDA temporarily lifted the in-person dispensing requirement for mifepristone. One clinic offered medication abortion up to 8 weeks' gestation, while the other two offered it up to 10 weeks.
Pregnancy at intake was based on self-reported last period or ultrasonography. Most patients received asynchronous care (72.3%) via secure text messaging, while the rest received synchronous care via video. There were two follow-up visits, one 3 to 7 days afterwards to confirm complete abortion, and one for a pregnancy test 2 weeks to 4 weeks later. Abortion outcomes were known for 74% of cases.
The primary outcome of effectiveness was defined as a complete abortion after 200 mg of mifepristone and ≤1,600 μg of misoprostol without any additional interventions.
Half of patients were 30 or older, and 4.6% were younger than 20. While race or ethnicity data were not known for a third of patients, most were white. Safety was lower for Black patients than white patients (99.3% vs 99.8%).
There were 15 total major abortion-related adverse events, and 10 patients were admitted to the hospital overnight, six had blood transfusions, and one had abdominal surgery to treat a ruptured ectopic pregnancy.
Upadhyay and team noted several limitations to their study, including the lack of clinic-level variation in both synchronous and asynchronous models. There were no cases of unexpected pregnancy duration past 70 days, which could potentially signal underreporting.
In the future, Upadhyay said that she wants to look at how to make telehealth abortions more accessible to people disenfranchised from medical care.
Disclosures
The CHAT study was supported by the BaSe Family Fund, the Erik E. and Edith H. Bergstrom Foundation, the Isabel Allende Foundation, the Kahle/Austin Foundation, the Lisa and Douglas Goldman Fund, Preston-Werner Ventures, and a Resource Allocation Program Award from the University of California San Francisco National Center of Excellence in Women's Health.
Upadhyay had no conflicts of interest.
One co-author reported receiving fees from Danco Laboratories, which distributes mifepristone, for staffing an FDA-mandated hotline.
Primary Source
Nature Medicine
Upadhyay UD, et al "Effectiveness and safety of telehealth medication abortion in the USA" Nat Med 2024; DOI: 10.1038/s41591-024-02834-w.