Is abortion reversal treatment safe?

15 March 2022

Last week news broke that Christian NHS doctor, Dermot Kearney, had been vindicated after a ban against him providing abortion reversal treatment to women in crisis pregnancies was dropped.

Supported by the Christian Legal Centre, Dr Kearney had been due to challenge the decision at the High Court, but the General Medical Council instead chose to drop the case against him with expert evidence stating that abortion reversal treatment he was providing was safe.

Abortion providers, however, consistently claim that APR is dangerous and should be banned but have failed to provide any credible evidence to support their position.

Here Dr Kearney debunks that position on the safety concerns raised:

A primary argument made by opponents of the use of Progesterone for Abortion Pill Reversal (APR) is that it is dangerous and can cause serious haemorrhage in women who receive the treatment. The only study regularly quoted by those who oppose APR was published in the journal Obstetrics and Gynecology in January 2020 under the title Mifepristone Antagonization with Progesterone to Prevent Medical Abortion. A Randomised Controlled Trial. The lead author was Dr Mitchell Creinin, an Obstetrician Gynecologist in Sacramento, California. [1]

In discussing the study results, the authors stated that it was discontinued at an earlier than planned stage because three women, out of twelve recruited, had to seek emergency help due to serious haemorrhage. Haemorrhage, it should be noted, including severe haemorrhage, is not uncommon following medical abortion.

Two of the three women in the study who suffered haemorrhage requiring emergency care were given placebo following Mifepristone administration. Only one had received Progesterone. One of those three, notably in the placebo group, required a blood transfusion. The main author of the study, Dr Creinin, an outspoken critic of APR, stated that enrolment for the study was discontinued prematurely “for safety reasons after the third patient required emergent evaluation and a transfusion.” It had been intended to recruit forty women in total for a complete study.

Citing this study, it has been concluded by opponents of APR that Progesterone administered in this context represents a serious danger to women. When the limited findings of this study are properly scrutinised, however, entirely different conclusions may be reached:

  • The study is too small for any firm conclusions to be derived from it.
  • Even if the findings are accepted to have some validity, it is observed that the risk of haemorrhage was reduced by 50% with Progesterone as opposed to expectant management alone (using placebo). Expectant management is currently recommended by the NHS and by the Royal College of Obstetricians and Gynaecologists in situations where women change their minds about proceeding with abortion after they have taken Mifepristone. The findings in this study suggest that administering Progesterone is much safer than expectant management alone. There was no evidence in this study that giving Progesterone after Mifepristone represented an increased risk of serious haemorrhage.
  • The foetal survival rate following Mifepristone administration in this limited study was doubled with Progesterone administration as opposed to expectant management alone (with placebo). After 15 days of treatment with either Progesterone or placebo, four out of five women treated with Progesterone were still pregnant with viable pregnancies. Two out of five in the placebo group were still pregnant. Two women, one in each group, had voluntarily withdrawn from the study at earlier stages.

This limited study therefore suggests that APR using Progesterone after administration of Mifepristone is both more effective and safer than expectant management alone for women who might wish to preserve their pregnancies and who have effectively withdrawn consent from continuing with abortion.

This creates a major dilemma for abortion providers. If they claim that APR with Progesterone is dangerous, citing the Creinin study as the only “evidence” for this, they are admitting that expectant management after Mifepristone without follow-up Misoprostol is at least, if not more, dangerous than administering Progesterone. If they insist that a woman should therefore take Misoprostol to complete the abortion, against her will, they are denying her the right to withdraw consent from “treatment” and are possibly enforcing a criminal act by forcing abortion against her will. It is against the law to force a woman to undergo an abortion against her will.

Other flaws with the study are related to the motivation and study design. Dr Creinin has been an outspoken critic of APR for many years. He and many colleagues in the USA have been disturbed by legislation passed in a number of states that require women undergoing medically-induced abortion to be informed that there is a reversal treatment available if they change their minds after taking the first abortion drug, Mifepristone. The reversal treatment, of course, is Progesterone.

Before the study was carried out, Dr Creinin was quoted as saying that if the results showed the Progesterone didn’t work, he hoped that it would “discourage state legislators from mandating that doctors tell their patients about an ineffective treatment”.

This interview with Dr Creinin might suggest that the main investigator designed and entered into this study with an intention to seek a pre-determined outcome with a plan to demonstrate that Progesterone therapy in APR was ineffective.

Similarly, the cohort group of women participating in the study was cohort selection process was subject to bias as none of them actually wanted to preserve their pregnancies and save their babies. All of them were due to undergo surgical abortions but had been asked to postpone the procedure for 15 days to allow them to take part in the study. In real life, women seeking APR actually want to preserve their pregnancies. The study did not include any women committed to the possibility of saving their babies and therefore does not represent real life situations.

Dr Creinin claimed that a proper statistical analysis was carried out before enrolment took place and that it was calculated that a cohort of forty participants (twenty in each group) would be sufficient to demonstrate a statistically-significant difference between the Progesterone and Placebo-treated groups, if such a difference actually existed. It is difficult to see how this could be so. Most studies that attempt to demonstrate statistically-significant differences in treatment outcomes require hundreds, or even thousands, of participants. Furthermore, a study of this type with a biased cohort, was always very likely to have a dropout rate among the participants before the scheduled end. This does not seem to have been taken into account. Two women, one in each group, out of the twelve enrolled, exited the study prematurely, both within a matter of days of commencing treatment.

Finally, while the authors claimed that the reason for stopping the study prematurely was the concern over the risk of severe haemorrhage among study participants, it is possible that the real concern for the investigators may have been related to the observation that foetal survival rates were twice as high in the Progesterone-treated group compared to the survival rate in the Placebo-treated group. Similarly, it may have been concerning for Dr Creinin and colleagues that the serious haemorrhage risk was doubled in the Placebo-treated group relative to that in the progesterone-treated group. It might be considered that these findings were not what the authors had wanted to see. These observed results are not described in any detail by the authors in the study discussion.

[1] (Creinin MD, Hou MY, Dalton L et al. Mifepristone Antagonization with Progesterone to Prevent Medical Abortion. A Randomised Controlled Trial. Obstet Gynecol 2020;135:158-65).
Find out more about Dr Dermot Kearney
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