Label comprehension of a combined mifepristone and misoprostol product for medical abortion: A pilot study in South Africa.

Objectives: As an important next step in developing an over-the-counter (OTC) misoprostol-mifepristone product, this study aims to assess the comprehension of a medical abortion label.

Study Design: We conducted a pilot study utilizing convenience sampling to enroll women in rural and urban communities at four sites in two South African provinces. Trained, female recruiters prescreened and consented potential participants. Included women were aged 16-45 with some literacy (assessed by Rapid Estimate of Adult Literacy in Medicine). Exclusion criteria were having ever used or assisted someone with a medical abortion. Demographic data were collected after enrolment. We gave women time to read the prototype label, then asked a series of 35 questions to assess key concepts for correct use of the drug. For all questions but the indication, women could refer to the label while answering. We used descriptive, chi-square and regression analyses to assess comprehension of concepts.

Results: 100 women aged 16-45 years participated. Most reported prior sexual intercourse (91%), pregnancy (75%), and prior contraceptive use (male condom, 45%). Messages clear to participants (>90%) regardless of literacy were: when to consult a doctor before use (history of anemia or ectopic pregnancy), to respect the mifepristone- misoprostol interval, when to seek medical attention (heavy, prolonged or no bleeding) and that fertility returns quickly after abortion. The average scores were moderate for comprehension of all medical abortion label comprehension concepts: 79% for questions about the indication of the product; 73% for assessment of appropriate gestational age; 76% for screening out ectopic pregnancy; 80% for identifying contraindications to the medicines; 69% for instructions on use; 76% for when and for what conditions to seek medical care; and 60% for how to follow-up after abortion with a pregnancy test. Questions with lowest comprehension regarded medication timing, where women with higher literacy were significantly more likely to understand the label than among lower literacy levels.

Conclusions: Our prototype over-the-counter label for a combined mifepristone-misoprostol product for medical abortion in early pregnancy was moderately understandable to participants. Comprehension scores were largely dependent on literacy levels. To demonstrate an understanding of at least 80% for key concepts, the prototype label for a combined medical abortion product requires revision.