Pelvic Examination in Pregnancy

This study is designed to determine whether the pelvic examination (including bimanual and
speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower
abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with
the chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and
positive HCG will be considered for this non-inferiority-designed clinical trial. All
patients who present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and
have had serum or urine HCG testing and a formal ultrasound by a credentialed emergency
physician or radiology technician as part of standard of care will be screened for further
eligibility. Those patients with intra-uterine pregnancies < 16 weeks gestation seen on
ultrasound and meet inclusion criteria will then be asked to provide informed consent to
participate in the study. Randomization will occur after consent has been obtained. Half of
the patients will be randomized to receive pelvic examinations and the other half will not.
Further care will be determined by the treating attending physician. The primary outcome
will be a composite morbidity endpoint at 30 days, including return visits to the ED,
emergency surgery, need for transfusion, infection, or other missed source of bleeding/
pain. Secondary outcomes of interest include ED throughput time, and patient satisfaction.