"Inversion of abortion" with progesterone is being tested in a study: Shots

Dr. Mitchell Creinin never expected him to be able to investigate a treatment that, in his opinion, was not working.

Yet, next year, Creinin will spend about a research grant from the Society of Family Planning to test a treatment he deems doubtful – a treatment that has recently gained ground, mostly via the Internet, among opposing groups. . Abortion. They call it "the reversal of the abortion pill".

The technique – a series of oral or injected doses of the hormone progesterone administered for several days – has appeared outside the usual pathways of scientific testing, said Creinin, a medical researcher and professor at the University of California , Davis.

Creinin, an OB-GYN, has devoted most of her career to family planning research. He has studied topics ranging from different treatments for miscarriages to how women choose birth control methods.

Abortion, he says, has always been part of his practice and philosophy. "I have to provide these services to help women," said Creinin.

Proponents of the "reversal of the abortion pill" say that he can stop a medical abortion in the first trimester if progesterone is administered on time.

But Creinin says that progesterone treatments are at best ineffective in ending an already started abortion. And, says Creinin, promoting treatment can be potentially harmful by giving pregnant women misleading information that an abortion can be canceled.

Although critics of the reversal of the abortion pill have stated that the term was an improper and unproven term, it has been so convincing that it has already been enshrined in the laws of many states.

Lawmakers in Arkansas, Idaho, South Dakota and Utah have imposed in recent years a legal duty on medical abortion doctors to tell their patients that reversal "is an option. the treatment does not work.

Medical researchers like Creinin and the American College of Obstetrics and Gynecology are concerned with this trend.

"You create a law that is not based on science – absolutely no science," said Creinin.

Proponents of the technique say that they have evidence. But it's anecdotal, says Creinin, or comes from studies that lack rigorous controls. It is time, said Creinin, to conduct a formal study that can be final.

"I want to admit it," he says.

Choice of abortion

During the first 10 weeks of pregnancy, women seeking an abortion usually have two options: surgery or medical abortion (after that, only surgical abortions are performed).

The treatment regimen is based on a combination of two medications – mifepristone and misoprostol – that women usually take at 24 hours intervals.

Mifepristone pills work by blocking progesterone, a hormone that helps maintain a pregnancy. The second drug, misoprostol, contracts the uterus to complete the abortion. Studies suggest that 95-98% of women taking both drugs in the prescribed regimen will terminate the pregnancy without harming the woman. Surgical evacuation can complete the abortion, if necessary.

So what happens if a woman takes mifepristone, then changes her mind and wants to continue her pregnancy?

If the change of heart occurs within the first hour after swallowing the initial medication, his doctor may help to induce vomiting. If she has not yet absorbed the first medication, the process can be stopped before starting.

The biggest question, and for which the data is more obscure, is: what will happen if a woman takes the first drug, but never takes misoprostol, the second drug in the regimen?

According to the American College of Obstetrics and Gynecology, "up to half of women who take only mifepristone continue their pregnancy". (If pregnancy continues, mifepristone is not expected to cause birth defects, ACOG notes.)

In 2012, George Delgado, a San Diego doctor, said that he had found a chemical way to end the abortion process with greater certainty – a way to give more control to a woman who changed in opinion. He called his protocol "inversion of the abortion pill".

Family doctor, Delgado is called "pro-life" and not anti-abortion. He says that about a decade ago, he became interested in the 24 hours following a woman who takes mifepristone but before taking misoprostol.

He had received a call from a local activist saying that a woman needed Delgado's help. She had swallowed the first pill of the abortion plan, but had reconsidered her decision and no longer wanted to end her pregnancy.

"People change their minds all the time," says Delgado.

In hopes of helping the woman, Delgado has given her progesterone, a drug that has many uses, including for the treatment of irregular vaginal bleeding and as part of hormone replacement therapy during menopause. According to Delgado, if progesterone is helpful in these other ways, it could stop the action of mifepristone blocking progesterone and stop an abortion.

Delgado says that the pregnancy of this first patient continued without incident, which he attributes to progesterone.

He then began administering progesterone treatment to a larger number of patients. He then developed a network of clinicians across the country ready to administer progesterone to patients who no longer want to have an abortion, although he did not specify the number of clinicians who participated looking for him.

These days, says Delgado, most women who consult him for progesterone treatment are self-referencing. When searching online, many find the website of the relief network for abortion pills, a national group of clinicians who provide treatment.

The network is supported by Heartbeat International, an abortion advocacy group, and according to spokesperson Andrea Trudden, includes more than 500 clinicians willing to prescribe progesterone to patients who have begun the process of ## 147 ## Drug abortion.

In support of their claims regarding the cancellation of the abortion pill, Delgado and his colleagues published their research in medical journals.

In 2012, Delgado co-authored a report in the Annals of pharmacotherapy about the experiences of six pregnant women who received mifepristone and then progesterone injections. According to the newspaper, four of the women were able to complete their pregnancy.

In a statement released in August 2017, ACOG stated that the results of the study, a type known as a series of cases not including a comparison group, "do not constitute scientific evidence that progesterone has resulted in the continuation of these pregnancies. " The ACOG statement also stated: "Case series without a control group are among the weakest medical evidence."

In 2018, Delgado and his colleagues in his healthcare provider network published a larger case series, involving 754 patients, in the journal Matters of Law and Medicine. The paper concluded that the reversal of the effects of mifepristone with progesterone "is safe and effective".

The researchers acknowledged that the study did not randomly assign women to placebo or mifepristone. Such a study, called a randomized placebo-controlled trial, would provide strong evidence. But Delgado and her colleagues wrote that performing this kind of lawsuit "in women who regret their abortion and want to save their pregnancy would be unethical".

"There is no alternative treatment," he says. "You can not always wait for the [randomized, controlled trials]. If it saves life, there is no alternative. "

State Legislatures Consider Legislation to "Cancel Abortion"

One of Delgado's most virulent critics, Dr. Daniel Grossman, an OB-GYN from the University of California at San Francisco, said that all published studies supporting this use of progesterone have been tainted methodological flaws that inflated the "success rate" of the inversion treatment.

Last October, Grossman and Kari White, a sociologist at the University of Alabama in Birmingham, who studies family planning, wrote an editorial in the New England Journal of Medicine criticizing Delgado's research methodology, claiming that he was using erroneous statistics and did not set rigorous criteria for the characteristics that patients had to complete to be included in the study.

"A systematic review that we co-wrote in 2015 found no evidence that continued pregnancy is more likely after progesterone treatment compared to the management expected in women who had taken mifepristone," wrote the editorialists.

"I think there is a strong prejudice against the reversal of the abortion pill," Delgado replied. "The ACOG characterizes this bias by formulating strong statements … It's a new science, but we have a significant amount of data, and it has been proved that these measures were safe. "

Critics have not slowed down Delgado's supporters.

Already in 2019, lawmakers in several states – Kansas, Kentucky, North Dakota and Nebraska – were considering bills that would require abortion providers to inform their patients of the reversal of abortion. . In 2017, Delgado testified in favor of similar legislation in Colorado, although the proposal has never been passed.

Grossman is furious that states are forcing abortions to give their patients inaccurate information about abortion-related care.

What's more, says Grossman, "these laws go a step further … and essentially encourage patients to participate in clinical research that is not subject to adequate oversight." Is really an experimental treatment ".

Progesterone has not been evaluated by the Food and Drug Administration to cancel a medical abortion. Doctors are allowed to prescribe drugs for uses not approved by the FDA as part of the practice of medicine. This is what is called improper use.

Until Delgado published his article in 2018, Delgado informed his patients that they were receiving a "new treatment". He says that he thinks that there is now enough research to support routine non-prescription prescription of progesterone in women who do not want to undergo a drug-based abortion.

"We now have a lot of data, there is no alternative, it has been proven that she was safe," Delgado said. "Why do not you give him a chance?"

Although Creinin does not share the view that evidence supports this use of progesterone, he understands that women who seek abortions may not be sure of the decision made on their first appointment. Creinin says that he supports policies that allow women to control as much as possible the decision to terminate or not a pregnancy.

"There are people who change their minds," says Creinin. "It's a normal part of human nature."

The UCSF Grossman accepts.

It encourages abortion providers, whenever possible, to send mifepristone and misoprostol home with the patient, if she requests it. Thus, she can only begin the protocol if and when she is ready, rather than making the decision in a clinic where she might feel pressured. (FDA rules on mifepristone stipulate that the pill can only be administered in certain types of clinics – usually clinics offering abortions – and some states place additional restrictions on the mode and location of prescription and abortion. use of medicines.)

Put the reversal of abortion to the test

The Creinin study, approved by the UC Davis Institutional Review Panel in December, was registered with ClinicalTrials.gov, which tracks medical research.

The study should include 40 pregnant women between 44 and 63 days of pregnancy who wish to have a surgical abortion. As a condition of the research, women should be willing to take mifepristone, the initial pill that would normally trigger medical abortion, then placebo or progesterone

Two weeks later, researchers will see if there is a difference between rates of continuing pregnancy. If progesterone can prevent the effects of mifepristone, says Creinin, he will find that more and more women in the progesterone group are still pregnant, with an ongoing pregnancy.

According to the researchers, the essential ethical point is that all the women in this study want to have an abortion and that they will have one by the end of the study. The study does not record women seeking a "reversal". They will be told from the outset that if mifepristone does not cause an abortion, they will be offered a surgical abortion.

Creinin says that study participants will be paid for the time they have spent studying, but will not be paid for an abortion. And patients will always be responsible for the cost of the surgical procedure – through their insurance or their pocket.

Creinin is skeptical about the effect of progesterone, as mifepristone is thought to irreversibly block progesterone in the body.

But if it has a clinically significant effect, he says, "I want to know it."

Creinin hopes that her work will help medical researchers better understand if this type of treatment can really help women who change their minds after taking mifepristone for medical abortion.

If the results show that progesterone does not work, Creinin hopes that it will deter state lawmakers from requiring doctors to inform their patients of ineffective treatment.

Creinin began recruiting patients for the study in February. He does not know how long the study will take, but says it's unlikely to have any preliminary results for at least a year.

Dr. Mara Gordon is a Health and Media Fellow in the Department of Family Medicine at the Georgetown University School of Medicine.