Study Claims, But Fails to Show “Self-Managed” Chemical Abortions “Highly Effective and Safe”

By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research

Another day, yet another study from abortion advocates claiming that Do-It-Yourself (DIY) or “self-managed” chemical abortions are safe and effective. 

This latest one is a study of about a thousand pregnant women in Argentina and Nigeria – where abortion was illegal at the time – who took different combinations of abortion pills.  It was done, of course, by the fine, objective researchers at the Ibis Reproductive Health, long known for their abortion advocacy.

The idea is clearly to build up momentum for worldwide authorization and use of abortion pills ordered online or over the phone and delivered by mail, so that women in industrial as well as developing nations can have these bloody, painful, dangerous abortions at home and never have to visit the clinic.

They were dangerous before, and they will be even more dangerous if these pills are going to given to women without any supervision or realistic emergency plan.

Study Results and Claims

The study, with the lengthy title “Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE):a prospective, observational cohort study and non-inferiority analysis with historical controls,” was published online November 18, 2021, in The Lancet. It was produced by a team of international abortion researchers from Ibis Reproductive Health, headquartered in Oakland, California but with offices in Nigeria, South Africa, Indonesia, and Argentina.

Researchers said that 1,237 women contacted a local “abortion accompaniment group” to enquire about the method. After 186 were ruled out as ineligible, not interested, or unwilling to undergo the procedure, 1,051 completed the initial questionnaire and consented to be part of the study.

Of those, 356 took the standard mifepristone + misoprostol regimen familiar to those in the United States, while 593 tried using misoprostol alone to chemical abort their children.  Two used some unknown regimen, ten received but did not take the drugs, and 90 were lost to follow up before their full outcomes were known.

From this, researchers to have obtained an efficacy rate of 97%, a complete abortion without any surgical intervention, for women using either regimen.

Efficacy, rather than safety, was the immediate focus of this study, but researchers claimed that 82% of participants reported no warning signs of complications. That, of course, means nearly one in five reporting issues such as heavy bleeding, foul smelling or colored discharge, fever, or debilitating pain.

Just over 20% sought care from a hospital or clinic at some point, most to confirm completion of the abortion, though 21 patients came in with concerns about pain, bleeding, discharge or fever.

On the basis of these results, authors announced that “self-managed medication abortion with accompaniment support is highly effective and safe.” They argued that going forward, governments and clinicians should “rely on evidence to guide their policies and practices towards self-managed approaches for medication abortion and focus on expanding access to medication abortion across a range of service delivery models, including self-use.”

Significant Flaws Plague this Study

Some spin is expected among researchers angling to promote their pet project, but this study, like many similar others that came before it, is riddled with significant holes.

Less “self-managed” than portrayed

First, though presented as an evaluation of “self-managed” care, there was a great deal more involvement by medical professionals than an actually “self-managed” method would seem to allow.  Patients in the Ibis study were screened, checked for possible contraindications (conditions such as blood disorders, allergies that might make the drugs particularly dangerous for her), checked for age, symptoms of ectopic pregnancy (which these pills do not treat), etc.

It is unclear whether this was done in person or over the phone or internet. But some appear to have had their pregnancies dated by ultrasound which would have necessitated some direct personal contact with a professional health care provider. The pills are less efficacious the farther along a woman is in her gestation.

(Some determined their gestations by estimating the time since their last menstrual period, which is less exact and subject to error.  If simply depending on recall or disclosure by the patient, incorrect dates may be given, so that pills may be given to women for whom they are less likely to work.)

In a self-managed abortion where a woman orders her pills over the internet after filling out a questionnaire (if that) or merely talks to a sales person over the phone, this critical information about gestational age, contraindications, even basic instructions that has an enormous impact on safety and efficacy may not get shared.

A certain percentage also visited the clinic or hospital to confirm their abortions or to have complications addressed.  If these abortions are to be truly “self-managed” and the pills made available to women who do not live close to or have ready access to medical care – those for whom the DIY model is offered or even designed – the medical services available to women in this study to address the uncertainty, the possible failures, potentially serious complications may well not be available to women attempting this in the real world.

Thus, despite the claim to have established the safety and efficacy of self-managed DIY abortion, the study did not actually address those conditions as they will play out on the ground.

More screening than expected in the field

Second, related to the first, the screening done here – which would not necessarily be done in the field – may have artificially contributed to higher efficacy and safety rates.

One reason that the screening is done in person, that there are ultrasounds to definitively determine gestational age, is because these are critical elements to eliminating patients for whom the drugs would not work or might prove dangerous.  To project that these rates, obtained with some form of screening, some ultrasounds, some form of direct contact would apply to women who are not screened, or are only screened by a questionnaire is entirely unwarranted. It is quite different when women merely offer a “best guess” estimate of their last menstrual period (or give a date that they think will get them the pills. To report safety and efficacy rates where many women had or took adavantage of ready access to professional medical help as applicable to situations where they do not is disingenuous at best and dishonest at worst.

A real world sample, where women on their own simply ordered the pills off the internet if they wanted them, would have women with gestations considerably higher than the 10 weeks recommended by the FDA; indeed, this study had a number of women who attempted these at gestations between 12 and 22 weeks, with higher failure rates. They would also have had women with undetected ectopic pregnancies (which this study screened out) which these pills do not treat.

Too many lost to followup

Third, in this study as in many of the others defending self-managed, telemedical, or merely chemical abortion, there were an inordinate number of patients lost to follow up.  To assume that these patients successfully aborted or otherwise fared well – when the issue is precisely how well patients manage when outside the supervision or monitoring of health care professionals – is not only irresponsible, but borders on being misleading.

Though reporting an efficacy rate of 97% for all regimens, researchers admit that the rate would drop to 91% if those lost to follow up were included as non-successes.

Even if some of those women did eventually abort, this does not tell us whether those lost to follow up may have been those more likely to abandon the program and seek outside help because of problems. A woman hemorrhaging, dealing with an infection may not see the point of contacting a hotline or the group that gave her the pills, but rather may simply head to her nearest emergency room (or her family doctor or personal Ob-Gyn) if there is one close by.

Thousands of injuries are not acceptable

Finally, what self-managed abortion, abortion pill advocates fail to acknowledge is that, even with the high efficacy and safety rates they report, there are still a number of women for whom these pills don’t work, who end up at the hospital with bleeding issues, fever, possible infections.

Touting a 97% success rate may seem like a fair sign that a drug is usually or even generally effective. But when you are dealing with elective drugs like mifepristone and misoprostol which have the proven potential to put patients in the hospital (or worse, in the grave), any percentage other than 100% means, on a national scale, accepting the likelihood that thousands of healthy women are going to take your drug and are going to be injured or put their lives at risk.

That this is an acceptable outcome to abortion advocates says something troubling about their priorities and their commitment to women’s “reproductive health.”

Even with its flaws, what this study proves is that these drugs come with a significant degree of risk and cannot be safely used without careful screening and supervision. When the aim of your drug is not to preserve, but to take human life, should you really expect any different?