Seeking HELP beyond the pill: women's perceptions about informed consent for medication abortion. Mixed methods research. (Preprint)
Authors: Tsulukidze Maka , Di Cicco Gabriele , Longbons Cox Tessa , Rafferty Katherine A. , Grande Stuart W. , Skop Ingrid , Collison David 
Published: November 2024

BACKGROUND

Informed consent is essential for patient autonomy in all areas of clinical practice. The rapid expansion of telehealth abortion services and online access to abortion medication in the U.S. has raised concerns about whether women are adequately informed, especially regarding the risks and consequences of medication abortion.

OBJECTIVE

This study explored women’s perceptions of the information provided during the informed consent process for medication abortion, as well as their needs and preferences for understanding potential risks and side effects.

METHODS

We used an exploratory sequential mixed methods design. Phase I involved qualitative data collection and analysis of women’s experiences with informed consent during medication abortion. Phase II utilized these insights to develop a survey that assessed women who have had a medication abortion and the factors influencing their perceptions of feeling informed.

RESULTS

In Phase I, thematic analysis identified four key themes: 1) Seeking information about abortion symptoms and side effects; 2) Seeking emotional support; 3) Requesting urgent reassurance about the abortion process; and 4) Discussing the information provided. In Phase II, hierarchical regression analysis showed that concerns about fetal remains, mental and emotional health, and failed abortion (retained tissue) were significantly associated with feeling informed. Emotional responses, specifically feeling stressed, was associated with a lower sense of being informed, while feelings of happiness were linked to a higher sense of being informed. Integrated qualitative and quantitative findings revealed strong consistency. Women’s concerns about seeing and taking care of fetal remains, as well as mental and emotional health matched the theme of seeking emotional support. Women’s concern about failed abortion (retained tissue) was congruent with the theme of seeking information and advice on abortion symptoms and side effects. Stress was associated with the need for additional information about medication abortion process, urgent support, and reassurance.

CONCLUSIONS

Women seek information online primarily regarding two areas: abortion symptoms and emotional responses. Many women expressed confusion about the process, risks, and options, suggesting limitations in current informed consent practices. Commonly cited needs for additional information—specifically regarding bleeding, pain, and emotional well-being—highlight these gaps. Our findings indicate that women are not always fully informed about the risks and benefits of medication abortion, which can lead to preference misdiagnosis, when wrong treatment recommendations are provided to patients because their preferences are not assessed correctly. This study emphasizes the need for improved counseling and more comprehensive information provision to support informed decision-making. As medication abortion becomes more common in the U.S., further research is needed to evaluate and enhance the standard of care for informed consent in both clinical and online areas of practice.