First trimester vaginal bleeding is a common complaint seen in the Emergency Department (ED).  Patients are obviously stressed about the possibility of miscarriage while providers are stressed about missing diagnoses such as ectopic pregnancies.  There have been multiple studies questioning the interrater reliability of the pelvic examination. But is there added utility to the examination once the presence of an intrauterine pregnancy (IUP) has been established?

Clinical Question

Does the pelvic exam provide any added benefit to patients presenting with first trimester bleeding who have an IUP on US?


Women >/= 18 years of age who presented with a positive pregnancy test and either vaginal bleeding or lower abdominal pain with an IUP < 16 weeks


Pelvic exam in the ED


No pelvic exam in the ED


Primary: Composite Outcome at 30 days: Unscheduled return, subsequent admission, emergency procedure, transfusion, infection, and alternate source of symptoms)
Secondary: ED throughput time, Patient experience survey


Prospective, open-label, randomized, equivalence trial


Pelvic exam performed before consent and randomization
Admission to the hospital
Known history of cervical carcinoma
Non-English speaking
Current pregnancy because of in vitro fertilization
Suspicion for heterotopic pregnancy
Reported heavy vaginal bleeding (soaking of > 10 menstrual pads in 24 hours)
Hemodynamic instability (SBP < 90 mmHg or pulse rate > 110 beats/min)
Report of or suspicion for penetrating vaginal trauma
Intrauterine device in place
Clinical suspicion for an alternative syndrome requiring pelvic examination (i.e. appendicitis, PID, or torsion)
Reported sexual assault
Previous enrollment in the trial
Inability to follow up by telephone

Primary Results

  • Study designed to enroll 720 patients with a predefined margin of +/- 8% for equivalence
  • Eligible patients: n = 405
    • 221 randomized, 202 patients analyzed
    • 75/184 eligible patients who declined did so because they did not want a pelvic examination
    • 4/184 eligible patients who declined did so because they wanted to have a pelvic exam

Critical Results

  • Composite endpoint (primary outcome)
    • 19.6% (no pelvic exam) vs. 22.0% (pelvic exam)
    • Absolute difference: – 2.4% (90% CI -11.8% to 7.1%)
    • The difference in primary composite outcome was driven by unscheduled return visits to the ED: 13.7% (no pelvic exam) vs 18.0% (pelvic exam)
  • Secondary endpoint
    • Patient who reported feeling uncomfortable or very uncomfortable
      • 11.2% (no pelvic exam) vs. 23.7% (pelvic exam)
      • Absolute difference – 12.5% (95% CI -23.0% to – 2.0%)
      • No statistical differences in ED LOS or perceived thoroughness of care


  • Largest prospective randomized study looking at the utility of the pelvic exam in the ED
  • First study with 30-day follow-up for outcome measures
  • Only lost 17 patients to follow up


  • Convenience sample of patients. May have missed patients with 1st trimester vaginal bleeding
  • There was a long list of exclusions for enrollment decreasing clinical applicability
  • Ultrasonography performed by radiology or in the ED under the supervision of an ultrasonography credentialed EM physician (Neither of these may be an option at some facilities)
  • This study did not have adequate sample size to reach statistical power (Required 720 participants and were only able to analyze 202)
  • Only patients with ultrasound confirmed IUP were enrolled in this study (i.e. Patients with indeterminate US results or clearly identified ectopic pregnancies were excluded)
  • Not possible to blind patients, providers, or research assistants to pelvic exam vs no pelvic exam
  • Used a composite primary endpoint instead of individual morbidity endpoints

Author's Conclusions

“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.”

Our Conclusions

The omission of the pelvic examination did not significantly increase morbidity in patients with 1st trimester vaginal bleeding. However, the study was underpowered to show equivalence of the two approaches.

Potential Impact To Current Practice

This paper should not change your practice of performing a pelvic exam in 1st trimester vaginal bleeding based on it’s inadequate enrollment to demonstrate equivalence.

Bottom Line

Although the evidence is starting to mount against the utility of the pelvic exam in the ED, this study was not powered to detect a difference in performing vs not performing a pelvic exam on morbidity outcomes.

Read More

EM Lit of Note: The End of the “Emergency” Pelvic Exam

ALiEM: Is the Pelvic Exam in the Emergency Department Useful?