Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
High-dose progesterone to reverse mifepristone held still “experimental”
Key clinical point: High-dose progesterone as a mifepristone antagonist in medical abortion still considered experimental.
Major finding: Study investigating high-dose progesterone to reverse mifepristone ends early because of hemorrhage in 3 of 12 women, 1 in the progesterone group and 2 in the placebo group.
Study details: Double-blind, placebo-controlled, randomized trial of 12 women.
Disclosures: The Society of Family Planning Research Fund supported the study. One author declared a consultancy with a laboratory providing medical consultation for clinicians regarding mifepristone, and a second author was an employee of Planned Parenthood. No other conflicts of interest were declared.
Creinin M et al. Obstet Gynecol. 2019, Dec 5. doi: 10.1097/AOG.0000000000003620.
I think that this study highlights the importance of scientific rigor approved by an institutional review board when we counsel and care for our patients. As ob.gyns., we have to remember the privilege that women entrust us with their health and well being. To a certain extent, we also care for their families within our scope of reproductive health. We practice based on the best evidence available and consider referral to another trusted provider when we feel that we cannot provide unbiased care. I also feel obligated to share my opinion that legislators should trust the scientific and clinical community to not only prioritize women and their health, but also avoid introducing legislation that infringes on medicine.
I applaud the investigators for the innovation of the study design and complying with their ethical duty to terminate the study early given safety concerns. I also appreciate the authors’ transparency in presenting outcomes for all subjects. Other case reports on this topic have presented only positive outcomes (i.e., continuing pregnancies/deliveries) which represent a fraction of the study population. Given the complicated outcomes experienced by some subjects in Dr. Creinin’s study, I am curious about the outcomes of the other subjects in previous case reports who didn’t have positive outcomes (i.e., those who did not have continuing pregnancies).
Catherine Cansino, MD, MPH, is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Creinin et al. article. Dr. Cansino is on the Ob.Gyn. News editorial advisory board.