Research Shows Ultrasound Is Not Necessary for Medication Abortion
Researchers suggest reproductive health providers could offer patients a faster, less expensive medication abortion via telemedicine. Study findings show that omitting the pre-abortion ultrasound does not appear to compromise safety or result in more ongoing pregnancies.1
“This was secondary analysis of a large study that’s been going on since 2016,” says Elizabeth Raymond, MD, MPH, senior medical associate with Gynuity Health Projects in New York City.
The researchers studied the safety and feasibility of providing patients with a medication abortion without visiting an abortion clinic in person. Instead, they could meet with a provider via videoconference.
“If any tests are needed, providers could arrange for the person to get the test at any location convenient to the patient,” Raymond says. “Then, the provider would dispense medications by mail to patients and follow up if further tests are needed.”
While international organizations have made medication abortion available without in-person visits, this was the first time the U.S. government permitted an American research project to study tele-abortion, Raymond says.
“One reason we did this as a research study is because the FDA regulates mifepristone and has strict regulations that require the pills to be dispensed to patients in a clinic, office, or hospital,” she says. “Mailing the drug was not allowed by the FDA.”
The researchers wanted to see whether any safety or medical reasons exist for prohibiting abortion services via telemedicine. “Our main analyses from the study have found that there wasn’t any problem with mailing the pills,” Raymond says. “This approach of using direct-to-patient telemedicine with mailing the pills was safe, feasible, and highly acceptable to patients and clinicians.”1
The study’s relevance grew overnight when many reproductive health clinics reduced in-person appointments during the early months of the COVID-19 pandemic.
“It became difficult for people to go to doctors, so this [tele-abortion] service we had started became really relevant during the COVID-19 pandemic,” Raymond notes. “It meant the patient didn’t have to travel to the abortion clinic.”
Standard practice required patients to undergo ultrasounds. This also became more challenging during the pandemic.
“We had been doing research to see whether that ultrasound test was necessary or whether eligibility could be determined by talking to patients, asking them about their last menstrual period,” Raymond says.
“The key thing is to determine whether the patient was pregnant, the gestational age, and whether the pregnancy is in the uterus vs. ectopic,” she adds. “The research made it clear that most patients could do a pregnancy test to determine pregnancy, and we could reasonably assess gestational age by asking questions.”
Abortion provider organizations reviewed the data and concluded that an ultrasound was not necessary for most patients. “Providers started offering medication abortion without a prior ultrasound,” Raymond says. “For most patients, the ultrasound could be eliminated, and the patient would not need to go out of the house; she could talk to the provider by video. Some providers began to implement that option.”
Some clinics enrolled in the tele-abortion study continued to perform an ultrasound on every patient after the pandemic began. Other clinics required an ultrasound on a case-by-case basis. All the enrolled clinics were in states where the ultrasound was not required by state law and tele-abortions were not prohibited.
“There are about half the states where this tele-abortion approach would not be legal, and Texas is one of them,” Raymond says.
Still, tele-abortion can be helpful to people who live in states that allow the practice, especially when driving to an abortion provider is a long trip. For many women who live in states where abortion medication cannot be mailed to them because of state laws, a workaround might be to travel to another state to pick up the mailed package. That happened with some women enrolled in the tele-abortion study.
“We had patients from 34 different states who got tele-abortions because they could travel,” Raymond explains. “We had patients crossing state lines to pick up their pills.”
Researchers compared tele-abortion patients who received ultrasounds to those who did not to look for differences in safety, medical care, costs, and other outcomes.
“We took data from those clinics and compared the patients who did get the ultrasound with those who did not get the ultrasound,” Raymond says. “It was not a randomized trial because clinicians were deciding about an ultrasound for each patient.”
The researchers tried to adjust for patient differences. For example, some patients may have had a last menstrual period that placed them closer to 10 weeks gestation. Others might have had their last menstrual period six weeks earlier, or the patient did not remember when the last period took place.
“The groups of patients are different, and those differences could affect the outcome, so we used statistical techniques to adjust for those differences,” she says.
Requiring patients to undergo an ultrasound increases cost and introduces a delay in abortion care, she notes.
Investigators also found that patients who did not get the ultrasound had a higher chance of the medication not working optimally. Some needed additional treatment, like an aspiration, to complete the abortion.
“But we also found they did not have a higher chance of serious problems — not a higher chance of being in the hospital or getting a transfusion,” Raymond explains. “We also found that abortions were much faster and cheaper without the ultrasound, so those are big advantages.”
The clinicians who participated in the study and who offered the medication abortion without an ultrasound thought this tradeoff was definitely beneficial for the patient, if it was what the patient wanted.
Because of the pandemic, the government lifted restrictions on mailing mifepristone to patients who sought a tele-abortion, and more clinics started using this approach outside of the study.
“They couldn’t do that before because it was not consistent with FDA restrictions, but because of the pandemic, the restrictions were lifted,” Raymond explains. “The lifting of the prohibition on mailing is only during the pandemic and will technically end.”
The FDA is reviewing regulation of mifepristone and may decide to lift restrictions permanently. “Regardless of the pandemic, the restrictions placed on mifepristone make no sense. This is a very safe drug, and there’s no reason why this medicine should not be mailed,” Raymond says. “The tele-abortion approach is highly convenient for some people, but it’s not going to solve all the problems of abortion access. What we need in abortion care is a range of options so that at least one thing will be suitable for a particular person, whatever the situation is.”
It is not ideal for people to cross state lines to access abortion care. But if they can receive abortion care while sitting in their homes, it is a good option, Raymond adds.
- Anger HA, Raymond EG, Grant M, et al. Clinical and service delivery implications of omitting ultrasound before medication abortion provided via direct-to-patient telemedicine and mail. Contraception 2021;S0010-7824(21)00342-5.
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