Pelvic Examination in Pregnancy (PEP)

Utility of Pelvic Examination in the Evaluation of Threatened Abortion

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Early Pregnancy Bleeding
• Intervention / Treatment: Procedure: Pelvic Examination; Procedure: No Pelvic Exam

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pelvic Exam; Subjects receive pelvic exam	Procedure: Pelvic Examination; Pelvic examination will be performed.
Experimental: No Pelvic Exam; Subjects do not receive pelvic exam	Procedure: No Pelvic Exam; Will not receive pelvic examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Satisfaction	24 Hours
Throughput Time	24 Hours

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Judith Linden, MD, Boston Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: H-31421