Pelvic Examination in Pregnancy (PEP)

Boston Medical Center (BMC)

Status: Completed

Conditions: Early Pregnancy Bleeding; Abdominal Pain

Treatments: Procedure: Pelvic Examination; Procedure: No Pelvic Exam

Study type: Interventional

Funder types: Other

Identifiers

NCT01570413

H-31421

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Pelvic Exam

Active Comparator group

Description:

Subjects receive pelvic exam

Treatment:

Procedure: Pelvic Examination

No Pelvic Exam

Experimental group

Description:

Subjects do not receive pelvic exam

Treatment:

Procedure: No Pelvic Exam