Clinical Trial: Risk Factors of Ectopic Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Risk Factors as Predictors of Ectopic PRegnancy

Brief Summary: The purpose of this study is to identify elements of a patient's demographics, history, and clinical presentation that may aid in differentiating between patients with an ectopic pregnancy, miscarriage, or normal intrauterine pregnancy. This study will also evaluate serial levels of human chorionic gonadotropin in the serum of these patients, as another way to make the diagnosis.

Detailed Summary:

The backbone of this protocol is the systematic evaluation of the presentation, work up, diagnosis and treatment outcome of women who present for evaluation of pain or bleeding in the first trimester of pregnancy and are therefore at risk for ectopic pregnancy (EP). Our focus is women whose diagnosis was not definitive upon initial presentation. We plan to collect systematic data regarding the current diagnostic strategies and treatment of these women and compare actual outcomes to those predicted by our newly developed strategies. This will be the first time such an endeavor has been conducted at multiple centers concomitantly. Expansion to two other sites is vital to ensure our preliminary data is valid and generalizable to women from different races and ethnicities, as well as to achieve the precision necessary to develop an accurate clinical tool. We will use a secure web-based clinical database (the Quantbook) to compile clinical information, and will download de-identified data to the research database once the diagnosis and clinical course of a patient has been completed. The Quantbook will be an expansion of a clinical database successfully utilized at Penn for the past 15 years. For a more detailed description of the Quantbook and research databases please see Attachment 2 of the full protocol. High quality information obtained from this cohort of women will allow the optimization and validation of our currently derived and proposed methods of diagnosis.

Data Collection Clinical Database (Quantbook): The clinician (e.g., attending physician, fellow, resident physician, nurse practitioner) who assesses the patient input information into the Quantbook. At the first presentation, this will include the patient's medical history, as well as presenting signs and symptoms. Results of tests ordered, including hCG and relevant chemistry, hematology, blood type, and ultras
Sponsor: University of Pennsylvania

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: September 13, 2005
Date Started: October 1999
Date Completion:
Last Updated: August 15, 2016
Last Verified: August 2016