We determine whether omitting the pelvic examination in emergency department (ED) evaluation of vaginal bleeding or lower abdominal pain in ultrasonographically confirmed early intrauterine pregnancy is equivalent to performing the examination.Methods
We conducted a prospective, open-label, randomized, equivalence trial in pregnant patients presenting to the ED from February 2011 to November 2015. Patients were randomized to no pelvic examination versus pelvic examination. Inclusion criteria were aged 18 years or older, English speaking, vaginal bleeding or lower abdominal pain, positive β–human chorionic gonadotropin result, and less than 16-week intrauterine pregnancy by ultrasonography. Thirty-day record review and follow-up call assessed for composite morbidity endpoints (unscheduled return, subsequent admission, emergency procedure, transfusion, infection, and alternate source of symptoms). Wilcoxon rank sum tests were used to assess patient satisfaction and throughput times.Results
Only 202 (of a planned 720) patients were enrolled, despite extension of the study enrollment period. The composite morbidity outcome was experienced at similar rates in the intervention (no pelvic examination) and control (pelvic examination) groups (19.6% versus 22.0%; difference –2.4%; 90% confidence interval [CI] –11.8% to 7.1%). Patients in the intervention group were less likely to report feeling uncomfortable or very uncomfortable during the visit (11.2% versus 23.7%; difference –12.5; 95% CI –23.0% to –2.0%).Conclusion
Although there was only a small difference between the percentage of patients experiencing the composite morbidity endpoint in the 2 study groups (2.4%), the resulting 90% CI was too wide to conclude equivalence. This may have been due to insufficient power. Patients assigned to the pelvic examination group reported feeling uncomfortable more frequently.