Clinical trial NCT01570413: Pelvic Examination in Pregnancy
Official title: Utility of Pelvic Examination in the Evaluation of Threatened Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Pregnancy Bleeding
Abdominal Pain
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Chief complaint of vaginal bleeding or lower abdominal pain
2. Intra-uterine pregnancy seen on ultrasound
3. Date \< 16 weeks by estimated LMP or ultrasound
4. Age \>21
5. Ability to provide written informed consent
6. English speaking

Exclusion Criteria:

1. Already enrolled in study
2. Morbid Obesity (BMI \> 40)
3. Pelvic exam performed prior to ultrasound results
4. Prisoner
5. Follow up cannot be assured
6. Admitted to hospital
7. Large amount of vaginal bleeding (\>10 pads in 24 hours or equivalent)
8. Unstable vital signs (SBP\<90 or HR\>110)
9. Known cervical carcinoma in the past 1 year
10. Clinical suspicion for alternative syndrome that requires pelvic exam (such as severe pain consistent with ovarian torsion)
11. Report or suspicion of penetrating vaginal trauma
12. Suspicion of Active Labor
13. Reported Sexual Assault
14. Current pregnancy by IVF
15. IUD in place
16. Suspicion of heterotopic pregnancy on ultrasound

Primary outcomes:
measure: Composite Morbidity Endpoint
timeFrame: 30 Days
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 24 Hours
measure: Throughput Time
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Judith Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.