Feasibility of recruitment for an efficacy trial of emergency contraceptive pills☆☆☆

Abstract 

Background

The efficacy of emergency contraceptive pills (ECPs) is currently uncertain. The best way to obtain a robust efficacy estimate would be to conduct a placebo-controlled randomized trial. We aimed to assess the feasibility of identifying women eligible for such a trial.

Study Design

We conducted a survey of women aged 18–35 years in five sexually transmitted disease clinics and urgent care centers in Kenya and the United States in 2006.

Results

Of 177 women surveyed, only 10 (6%) reported no reasons for exclusion from a potential efficacy trial. Of the rest, 149 (83%) had not recently had sex that conferred a substantial risk of pregnancy. At all sites combined, the rate of identification of potentially eligible women was 0.6 per day of interviewing.

Conclusion

A placebo-controlled efficacy trial of ECPs would likely require several thousand participants. Recruitment for such a trial in these types of sites would be prolonged.

Keywords: Recruitment, Efficacy trial, Emergency contraceptive pill