Enthusiasm, as measured by time-to-provider, for performing a pelvic examination in the Emergency Department is low. The logistics of a comfortable, adequate examination can be time consuming and detract from patient throughput. The yield of such examination is thought to be poor – enough so many providers, even absent sufficient evidence, choose to forgo the examination whenever reasonable, and depend on symptoms or advanced imaging to complete the evaluation.
This study aims to determine the acceptableness of the practice of forgoing the pelvic examination in a subset of vaginal complaints, those presenting with vaginal bleeding or abdominal pain in early pregnancy. From an ED standpoint, the typical most worrisome consideration is an ectopic pregnancy, with other diagnostic considerations important, but less salient. These authors developed a protocol in which women of fewer than 16 weeks gestation could be randomized to assessment with pelvic examination omitted or not. Their primary outcome was a composite pregnancy morbidity and utilization outcome at 30 days, with the trial designed to evaluate statistical equivalence between the two strategies.
Unfortunately, we have to give this trial a grade of “incomplete” for its ability to answer the research question – not the least because they under-enrolled their study cohort by over 500 patients. Of a planned enrollment of 720, they were only able to capture 202 due to slow enrollment due to a variety of factors. Furthermore, even if they had met their enrollment, I’m uncertain whether their composite outcome – chosen, almost certainly, to reduce the sample size needed to detect already rare outcomes – is clinically meaningful. Some elements of their composite morbidity outcome – unscheduled ED visits, hospital admissions, procedures relating to pregnancy – are of uncertain relationship to the decision to provide or withhold a pelvic examination at the time of first encounter. The most relevant of their composite is undoubtedly the identification of an alternative symptom source, but, again, this would require additional enrollment to detect a difference in such an infrequent outcome. Of the 202 patients included, 2 of 100 in the pelvic examination cohort had an alternative source for symptoms identified, but these are not specifically commented upon in the text.
Secondary outcomes relating to ED throughput and patient satisfaction favored the cohort omitting the pelvic examination, only ED length of stay suggests a potentially meaningful difference of approximately 20 minutes (not reaching statistical significance). Patient perceptions and concerns over embarrassment were not consistent across measures and assessment and probably not reliable.
Generally speaking, this study probably provides evidence supporting a strategy in which pelvic examinations are omitted, but this evidence is quite weak. The clinical significance of the information gleaned from a pelvic examination is unlikely to be of substantial clinical interested except in rare cases, and I would suggest the next steps in observational research to be to evaluate the clinical features of patients whose diagnosis or plan of care is changed by the pelvic examination.
“Is the Pelvic Examination Still Crucial in Patients Presenting to the Emergency Department With Vaginal Bleeding or Abdominal Pain When an Intrauterine Pregnancy Is Identified on Ultrasonography? A Randomized Controlled Trial”