Pelvic Examination in Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Utility of Pelvic Examination in the Evaluation of Threatened Abortion

Conditions
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Early Pregnancy Bleeding, Abdominal Pain

Intervention / Treatment
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* Procedure: No Pelvic Exam
* Procedure: Pelvic Examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Suspicion of heterotopic pregnancy on ultrasound

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Exam<br>Subjects receive pelvic exam | Procedure: Pelvic Examination<br>* Pelvic examination will be performed.<br>|
| Experimental: No Pelvic Exam<br>Subjects do not receive pelvic exam | Procedure: No Pelvic Exam<br>* Will not receive pelvic examination.<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction |  | 24 Hours | 
| Throughput Time |  | 24 Hours |