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NCT01570413 · ClinicalTrials.gov registry record · NA
Pelvic Examination in Pregnancy
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 220
- Enrollment target
NCT01570413 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 220 participants.
The verdict
NCT01570413, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 220 participants
- Enrollment target
Study 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
- PROCEDURE Pelvic Examination
- PROCEDURE No Pelvic Exam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01570413
The ClinicalTrials.gov registry entry for NCT01570413 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pelvic Examination is the first listed.
NCT01570413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01570413 about?
NCT01570413 is a clinical study titled "Pelvic Examination in Pregnancy". 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 vagi...
What is the current status of trial NCT01570413?
This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2012-02. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01570413?
The interventions under investigation include: Pelvic Examination (PROCEDURE), No Pelvic Exam (PROCEDURE).
Who is sponsoring clinical trial NCT01570413?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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