Progesterone After Mifepristone to Halt Medication Abortion: Is It Safe?
Study of progesterone stopped due to safety issues
EXECUTIVE SUMMARY
Results of a new study indicated that women who initiate medication abortion but opt to stop in the middle of treatment may be at risk for serious blood loss.
• In the past four years, legislators in at least 14 states have introduced bills that would require clinicians to inform patients during pre-abortion counseling that medication abortion can be “reversed” if the patient changes her mind after taking the first of two drugs needed for the procedure.
• The American College of Obstetricians and Gynecologists does not support the use of progesterone for “reversal” of medication abortion because the treatment does not meet clinical standards and is not based on scientific evidence.
In the past four years, legislators in at least 14 states have introduced bills that would require clinicians to inform patients during pre-abortion counseling that medication abortion can be “reversed” if the patient changes her mind after taking the first of two drugs needed for the procedure. However, results of a new study indicated that women who opt to stop in the middle of treatment may be at risk for serious blood loss.1
Medication abortion involves the use of two drugs, mifepristone and misoprostol, usually taken 24 to 48 hours apart. Mifepristone acts to block the pregnancy hormone, progesterone, while the misoprostol causes a woman’s body to expel the pregnancy. Approved by the FDA for medical abortion during the first 70 days of pregnancy, the abortion regimen is highly effective and safe. The complication rate for medication abortion is less than 0.5%, whether it is provided in-person or by telemedicine.2
A case study was published in 2012 that detailed the experience of six abortion patients who received high doses of progesterone after taking only mifepristone, the first of the two drugs needed to complete the regimen.3 Co-authored by an acknowledged antiabortion activist, George Delgado, MD, a San Diego physician, the study did not conform to minimum standards for medical research, according to a 2015 systematic evidence review. The study authors did not apply for ethical approval and did not use a control group.4 Results of a 2018 observational study, published by some of the same authors, reported the experience of 500 abortion patients who underwent medication abortion “reversal.”5 The 2018 study also did not follow a uniform course of treatment, and was not designed with a control group.
To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone, a research team led by Mitchell Creinin, MD, professor in the department of obstetrics and gynecology and director of family planning at the University of California, Davis, enrolled women who were planning a surgical abortion and willing to delay the procedure for two weeks. Participants ingested 200 mg of mifepristone and initiated 400 mg of oral progesterone or placebo 24 hours later twice daily for three days, then once daily until their planned surgical abortion 14-16 days after enrollment. Women were followed for up to two weeks after taking mifepristone to identify if the pregnancy continued to develop. Those with continuing pregnancies underwent a surgical abortion as scheduled.
Researchers reported that after enrolling 12 women in the study, three participants experienced severe bleeding, requiring ambulance transport to an ED. One woman received progesterone, and two had received placebo. Because of such safety issues, the research team stopped the study early.
“Without any evidence of efficacy, the findings of serious safety concerns in our study participants who received progesterone or placebo means that we should not be providing such treatment unless it is under strict research oversight,” states Creinin. “This treatment is experimental, and persons who [are] undergoing an abortion and may want this treatment deserve to be treated in the same safe manner as anyone receiving any new potential therapy.”
In 2015, Arkansas was the first state to implement mandatory abortion reversal counseling; Idaho, South Dakota, and Utah have adopted similar laws. Other states have pushed back against legislation. Bills introduced in California, Colorado, Georgia, and North Carolina failed to pass, and the Indiana Senate stopped a bill that had been passed by the House. In 2019, legislators in Kansas, Kentucky, North Dakota, and Nebraska also considered bills that would require abortion providers to tell their patients about abortion reversal.
In 2017, the Louisiana Department of Health performed a review of the effectiveness of “reversal” at the state legislature’s request. The review concluded that “there is insufficient evidence to suggest that there is a sound method to reverse a medication-induced abortion.”6
The American College of Obstetricians and Gynecologists (ACOG) does not support the use of progesterone for “reversal” of medication abortion because the treatment does not meet clinical standards, and is not based on scientific evidence.7 The use of progesterone for reversing a medication abortion has not been reviewed by the FDA. Such use in medication abortion “reversal” is considered off-label, since it has not been approved by the agency for such purposes.
“It is very concerning that states are passing laws to encourage women to participate in an unmonitored experiment,” says Creinin. “When a study is monitored, as ours was, we have the ability to stop if safety concerns arise.”
Is counseling on “reversal” necessary when women are seeking a medication abortion? Research indicates that most women who seek medication abortion are sure of their decision to have an abortion. In the days after an abortion, the majority of women report that it was the right decision.7 Fewer than 1% of patients who took mifepristone between 2000 and 2012 ended up deciding to continue their pregnancies.4
Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine, suggests that individuals who have been counseled on medication abortion reversal be informed that the practice is potentially dangerous, is not effective, and is not recommended by ACOG.
REFERENCES
- Creinin MD, Hou MY, Dalton L, et al. Mifepristone antagonization with progesterone to prevent medical abortion: A randomized controlled trial. Obstet Gynecol 2020;135:158-165.
- Grossman D, Grindlay K. Safety of medical abortion provided through telemedicine compared with in person. Obstet Gynecol 2017;130:778-782.
- Grossman D, White K, Harris L, et al. Continuing pregnancy after mifepristone and “reversal” of first-trimester medical abortion: A systematic review. Contraception 2015;92:206-211.
- Delgado G, Condly SJ, Davenport M, et al. A case series detailing the successful reversal of the effects of mifepristone using progesterone. Issues Law Med 2018;33:21-31.
- Louisiana Department of Health, Bureau of Family Health. Legislative Report on 2016 House Concurrent Resolution (HCR) 87: Study related to whether the effects of an abortion induced with drugs or chemicals can be reversed. April 12, 2017. Available at: https://bit.ly/38awdfI.
- American College of Obstetricians and Gynecologists. Facts are important: Medication abortion “reversal” is not supported by science. Fact sheet, August 2017. Available at: https://bit.ly/2tlNHH5.
- Rocca C, Kimport K, Gould H, et al. Women’s emotions one week after receiving or being denied an abortion in the United States. Perspect Sex Reprod Health 2013;45:122-131.
Results of a new study indicated that women who initiate medication abortion but opt to stop in the middle of treatment may be at risk for serious blood loss.
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