A small case study on the safety of the abortion pill reversal procedure that was cut short due to safety concerns does not accurately represent the safety and efficacy of the procedure to the public, a pro-life group has said.
“Pro-abortion researchers would rather continue to mislead women about the real risks of the abortion pill regimen Mifeprex than protect them from the risks of this dangerous drug,” Dr. Tara Sander Lee, senior fellow and director of life sciences for the Charlotte Lozier Institute, said in a statement.
Earlier this year, a group of researchers from the University of California at Davis attempted to study whether administering high doses of the hormone progesterone can successfully override the effects of the progesterone-blocking drug, mifepristone, the first of two pills taken in a medically induced abortion. The second drug, misoprostol, is taken up to two days later and induces labor.
This abortion pill reversal procedure is administered to women who have taken the first pill, mifepristone, but have changed their minds and do not want to continue with the abortion. Creators of the protocol say it has saved hundreds of babies whose mothers changed their minds about aborting.
According to an NPR report, while the researchers at UC Davis were hoping that 40 women would enroll in the study, only 12 did. Of those 12, three women were transported to the hospital for serious vaginal bleeding - one of those women had been given progesterone, the others had received a placebo.
Of the remaining participants, six of the women had a fetal heartbeat detectable on their subsequent ultrasounds, evidence of a continued pregnancy - four of them in the progesterone group, and two in the placebo group. Two women left the study and had surgical abortions.
The researchers stopped the study in July due to the lack of participants and safety concerns.
“Encouraging women to not complete the regimen should be considered experimental,” Dr. Mitchell Creinin, a professor of obstetrics and gynecology at UC Davis and the lead researcher on the study, told NPR. “We have some evidence that it could cause very significant bleeding.”
“It's not that medical abortion is dangerous,” he added. “It's not completing the regimen, and encouraging women, leading them to believe that not finishing the regimen is safe. That's really dangerous.”
Creinin, who has a long history of performing abortions, also told NPR that because the study was smaller than expected and cut short, it cannot answer the question it was intended to answer.
“Does progesterone work? We don't know,” he said. “We have no evidence that it works.”
Lee, however, said in her statement that the UC Davis study does not prove the dangers of the progesterone protocol, but rather the dangers of mifepristone, as two of the three women who experienced bleeding had not even been given progesterone.
“Long before this study was published, it was a known fact that Mifeprex (brand name of mifepristone) can cause serious and sometimes fatal infections, excessive bleeding, and incomplete termination requiring follow-up surgery. This study does nothing but further prove these serious, life-threatening risks when taking the abortion pill,” Lee said.
“The study was ended early because of severe hemorrhage in 25% (3 out of 12) of women, requiring emergency ambulatory care, because they took the abortion pill. Even the authors highlight that this is a rate much higher (42% higher) than previously reported. In fact, the bleeding was so bad for one woman, described as ‘significant brisk bleeding,’ that she needed a blood transfusion. She also developed hypotension and tachycardia.”
The progesterone protocol for an abortion pill reversal is available at several pro-life clinics throughout the United States. While the procedure has not been approved by the FDA, many pro-life medical professionals consider it safe, as progesterone is a hormone that naturally occurs in and helps sustain pregnancy, and is used to treat some pregnancies at high risk of miscarriage.
Teresa Kenney, a women's health nurse practitioner with the Sancta Familia (Holy Family) Medical Apostolate in Omaha, Nebraska, previously told CNA that because progesterone is safe for pregnant women and their unborn babies, and the benefit of reversing a medical abortion is so great, the procedure “makes complete sense” from a scientific standpoint.
“If I give a medicine that decreases or blocks progesterone to stop a pregnancy, then it makes perfect logical medical sense to give progesterone to help reverse that,” Kenney told CNA in September.
She added that the benefits are “overwhelmingly positive,” as the procedure in a sense saves two lives - that of the unborn child, and that of the mother who regretted her decision to have an abortion.
“Just because there hasn't been a randomized controlled double-blind study on abortion pill reversal doesn't mean that it doesn't make sense to implement it in medicine, because there is already scientific support for progesterone in early pregnancy in the prevention and miscarriage,” she said.
“Do we need more research? Absolutely. But to withhold treatment when, again, we know that it does no harm...we know that it medically makes sense, it scientifically makes sense, and the benefits are overwhelmingly positive, why wouldn't we do it?”
Dede Chism, a nurse practitioner and co-founder and executive director of Bella Natural Women’s Care in Englewood, Colorado, told CNA in 2018 that a recent case study had shown that the progesterone protocol was significantly more effective in helping women keep their pregnancies after taking mifepristone than if nothing was done.
That study, published in Issues in Law and Medicine, a peer-reviewed medical journal, examined 261 successful abortion pill reversals, and showed that the reversal success rates were 68% with a high-dose oral progesterone protocol and 64% with an injected progesterone protocol.
Both procedures significantly improved the 25% fetal survival rate if no treatment is offered and a woman simply declines the second pill of a medical abortion. The case study also showed that progesterone treatments caused no increased risk of birth defects or preterm births.
That study was authored by Dr. Mary Davenport and Dr. George Delgado, who have been studying the abortion pill reversal procedures since 2009. Delgado also sits on the board of the American Association of Pro-Life Obstetricians and Gynecologists.
Medical abortions make up a significant portion - roughly 30-40% - of total abortions in the United States. At least seven states, including Nebraska, Utah, Oklahoma, Arkansas, Arizona, Idaho and South Dakota, have laws mandating that women undergoing medical abortions or who are questioning their decision in the process be informed in some way of the option for a medical abortion reversal.
A North Dakota judge in September granted a temporary injunction against a proposed law in the state that would have required doctors to tell their patients that a medically-induced abortion could be reversed if the patient acted quickly.