Early Pregnancy Bleeding, Abdominal Pain
Conditions
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.
Interventions
PROCEDURENo Pelvic Exam
Will not receive pelvic examination.
PROCEDUREPelvic Examination
Pelvic examination will be performed.
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Morbidity Endpoint | 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
| Measure | Time frame |
|---|---|
| Patient Satisfaction | 24 Hours |
| Throughput Time | 24 Hours |
Countries
United States
Outcome results
None listed