Objectives To compare women who enrol in emergency contraception (EC) trials to those who decline and to understand why eligible women decline to participate. Methods Data were collected from all women seeking EC (n = 5787) at three clinics in the USA and UK during a period of nearly 1 year (from September 1997 to August 1998). The main outcome measures were pregnancy risk calculated by adjusted cycle day of ovulation. Results Enrolled and non-enrolled women had similar mean ages and similar mean cycle lengths. However, the enrolled and non-enrolled groups were different with respect to adjusted cycle day of unprotected sexual intercourse (UPSI), the regularity of their cycles, recent hormone use, breastfeeding, the number of other acts of UPSI they had engaged in during the same cycle, and their willingness to participate in the study. Expected pregnancy risk among enrolled patients was higher than among nonenrolled EC seekers (6.5% vs 5.0%, p<0.001, calculated using Dixon conception probabilities, and 5.4% vs 4.6%, p = 0.086, calculated using Trussell conception probabilities). Unwillingness to take part in the study was the most common reason women did not enrol in the trial. Otherwise-eligible women most often declined to enrol because they were concerned about the effectiveness of the trial regimen. Conclusions Women in EC trials are likely to face higher pregnancy risk than the general population. Clinical trials might overestimate the number of pregnancies averted by treatment because the number of expected pregnancies in trial populations is not representative of the population of all EC seekers. This information could be useful in projecting the public health impact of expanded EC access.
IntroductionEmergency contraception (EC) helps to prevent pregnancy after unprotected sexual intercourse (UPSI), and has the potential to reduce the incidence of unintended pregnancy and abortion. 1 Methods include a regimen of ordinary combined oral contraceptive pills or progestin-only pills taken within 72-120 hours after UPSI, and insertion of a copper-releasing intrauterine device (IUD) within 5 days.A number of clinical trials have explored the safety 2,3 and efficacy 4,5 of various EC regimens. Because there is consensus that the method is efficacious, placebo randomised trials are no longer ethical, and researchers must indirectly estimate the effectiveness of EC by comparing the pregnancy rates observed in a trial with expected pregnancy rates based on historic studies of women trying to conceive. We do not know of any studies that have evaluated the external validity of this method, namely the differences in pregnancy risk between women who enrol in EC clinical trials and EC users who do not. Our goal was to examine whether the conclusions drawn from trial populations are applicable to the general population of EC users. Additionally, analysis of the characteristics and reasoning of women seeking EC but not necessarily qualifying for or agreeing to join clinical trials of the method can aid us in int...