Pelvic Examination in Pregnancy

Abdominal Pain Clinical Trial

— PEP  

Official title:

Utility of Pelvic Examination in the Evaluation of Threatened Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570413
• Other study ID #: H-31421
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: May 3, 2017
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Early Pregnancy Bleeding

Intervention

Procedure:
• No Pelvic Exam
Will not receive pelvic examination.
• Pelvic Examination
Pelvic examination will be performed.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Patient Satisfaction		24 Hours
Secondary	Throughput Time		24 Hours