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

Plight of the pelvic exam

“…In 2017, Annals of Emergency Medicine published a study by Linden et al , suggesting that pelvic exams for ED patients with vaginal bleeding or lower abdominal pain, and ultrasound-confirmed first-trimester intrauterine pregnancy (IUP), may be unnecessary 4. This prospective, randomised equivalence trial measured the composite morbidity (unscheduled return, subsequent admission, emergency procedure, transfusion, infection and alternate source of symptoms) in the intervention (no pelvic exam) and control (pelvic exam performed) groups.…”

“…In fact, Linden et al reported that subjects for whom the pelvic exam was omitted were 12.5% less likely to report feeling uncomfortable 4. However, while patient comfort should not be ignored, the study was not designed to address this outcome, nor did it test other interventions—for example, gel warmer, specialised bed or speculum-bimanual sequence—to enhance patient comfort.…”

What do we learn from an equivalence study without statistical power?

“…Two simulated versions ofLinden et al (2017) with idealized versus implemented sample sizes. Each plot shows a random sample of 100 results from 10,000 simulations of each design.…”

What Do We Learn From an Equivalence Study Without Statistical Power?

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We were interested to read the article by Linden et al (2017) that claims to provide evidence to "support the safety of omitting a pelvic examination in women with a confirmed intrauterine pregnancy," (p. 833).1 In light of previous studies questioning the utility of the pelvic exam, this trial addresses a critical question for patients with threatened abortion. We commend the authors for conducting the largest randomized trial on pelvic exams to date, but several methodological issues raise questions about whether clinicians can make reliable inferences from this study.

First, the implemented experiment does not seem to have adequate statistical power to detect equivalence.

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“…We were interested to read the article by Linden et al (2017) that claims to provide evidence to "support the safety of omitting a pelvic examination in women with a confirmed intrauterine pregnancy," (p. 833).…”