Pelvic Examination in Pregnancy

NCT01570413 | Completed DMC

• 1 other identifier: H-31421
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Pregnancy Bleeding; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  24 Hours

• Throughput Time

  24 Hours

Study Arms (2)

Pelvic Exam

ACTIVE COMPARATOR

Subjects receive pelvic exam

Procedure: Pelvic Examination

No Pelvic Exam

EXPERIMENTAL

Subjects do not receive pelvic exam

Procedure: No Pelvic Exam

Interventions

No Pelvic Exam PROCEDURE

Will not receive pelvic examination.

No Pelvic Exam

Pelvic Examination PROCEDURE

Pelvic examination will be performed.

Pelvic Exam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, United States

Location

Related 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.

  PMID: 21691528 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.

  PMID: 17475104 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.

  PMID: 15208231 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.

  PMID: 20002713 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.

  PMID: 20159393 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Judith Linden, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Faculty

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: April 4, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)