Pelvic Examination in Pregnancy (PEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01570413
First received: February 27, 2012
Last updated: April 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Early Pregnancy Bleeding
Abdominal Pain
Procedure: No Pelvic Exam
Procedure: Pelvic Examination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Utility of Pelvic Examination in the Evaluation of Threatened Abortion

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Composite Morbidity Endpoint [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
  • Throughput Time [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570413

Contacts
Contact: Laura Hagopian, MD 617 414-4929 Laura.Hagopian@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States
Contact: Patty Mitchell, RN    617-414-4560    Patricia.Mitchell@bmc.org   
Principal Investigator: Laura Hagopian, MD         
Sub-Investigator: Judy Linden, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Laura Hagopian, MD Boston Medical Center
  More Information

Publications:
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01570413     History of Changes
Other Study ID Numbers: H-31421
Study First Received: February 27, 2012
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Hemorrhage
Abdominal Pain
Pregnancy Complications, Cardiovascular
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Pregnancy Complications
Cardiovascular Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014