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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Exam | Active Comparator | Subjects receive pelvic exam |
|
| No Pelvic Exam | Experimental | Subjects do not receive pelvic exam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Pelvic Exam | Procedure | Will not receive pelvic examination. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Morbidity Endpoint | Adverse events include, but are not limited to, return visits to the Emergency Department, need for hospital admission, emergency procedure, transfusion, infection, or identification of other source of symptoms. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 24 Hours | |
| Throughput Time | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Linden, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21691528 | Background | Brown J, Fleming R, Aristzabel J, Gishta R. Does pelvic exam in the emergency department add useful information? West J Emerg Med. 2011 May;12(2):208-12. | |
| 17475104 | Background | Brown T, Herbert ME. Medical myth: Bimanual pelvic examination is a reliable decision aid in the investigation of acute abdominal pain or vaginal bleeding. CJEM. 2003 Mar;5(2):120-2. doi: 10.1017/s1481803500008289. |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pelvic Examination |
| Procedure |
Pelvic examination will be performed. |
|
| 15208231 | Background | Hoey R, Allan K. Does speculum examination have a role in assessing bleeding in early pregnancy? Emerg Med J. 2004 Jul;21(4):461-3. doi: 10.1136/emj.2003.012443. |
| 20002713 | Background | Isoardi K. Review article: the use of pelvic examination within the emergency department in the assessment of early pregnancy bleeding. Emerg Med Australas. 2009 Dec;21(6):440-8. doi: 10.1111/j.1742-6723.2009.01227.x. |
| 20159393 | Background | Seymour A, Abebe H, Pavlik D, Sacchetti A. Pelvic examination is unnecessary in pregnant patients with a normal bedside ultrasound. Am J Emerg Med. 2010 Feb;28(2):213-6. doi: 10.1016/j.ajem.2008.10.018. |
| D012817 | Signs and Symptoms, Digestive |