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Pelvic Examination in Pregnancy (PEP)

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ClinicalTrials.gov Identifier: NCT01570413
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Early Pregnancy Bleeding Abdominal Pain Procedure: No Pelvic Exam Procedure: Pelvic Examination

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Utility of Pelvic Examination in the Evaluation of Threatened Abortion
Study Start Date : February 2012
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Composite Morbidity Endpoint [ Time Frame: 30 Days ]
    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 :
  1. Patient Satisfaction [ Time Frame: 24 Hours ]
  2. Throughput Time [ Time Frame: 24 Hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570413


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Judith Linden, MD Boston Medical Center