Pelvic Examination in Pregnancy (PEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01570413|
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Early Pregnancy Bleeding Abdominal Pain||Procedure: No Pelvic Exam Procedure: Pelvic Examination||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utility of Pelvic Examination in the Evaluation of Threatened Abortion|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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.
- 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.
- Patient Satisfaction [ Time Frame: 24 Hours ]
- Throughput Time [ Time Frame: 24 Hours ]
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
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States|
|Principal Investigator:||Judith Linden, MD||Boston Medical Center|