Risk Factors of Ectopic Pregnancy

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Brief Title

Risk Factors of Ectopic Pregnancy

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 Description

      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 ultrasound, will be entered. The
      clinician will assign a clinical impression (which may be a final definitive diagnosis, or a
      suspected diagnosis, or "unable to determine"). Follow-up contacts and assessments are
      recorded as they occur. Each time the patient returns for an assessment, the clinical
      impression can be updated, until a definitive diagnosis is made. A research coordinator will
      be tasked to monitor the Quantbook to provide quality control that the clinical data entered
      is complete and correct.
    


Study Type

Observational




Condition

Ectopic Pregnancy



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

3000

Start Date

October 1999

Completion Date

January 2007

Primary Completion Date

January 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Reproductive-aged women

          -  Currently pregnant based on serum human chorionic gonadotropin test

          -  Present for care for vaginal bleeding and/or pelvic pain

          -  Final diagnosis of:

               1. Ectopic pregnancy

               2. Miscarriage less than 14 weeks gestation

               3. Ongoing normal intrauterine pregnancy less than 14 weeks gestation

          -  Entered into clinical tracking database

        Exclusion Criteria:

          -  Patients not entered in clinical tracking database, or with insufficient information
             recorded to analyze (e.g. missing final diagnosis)
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Kurt T Barnhart, MD, MSCE, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00194207

Organization ID

103700

Secondary IDs

R01HD036455-01A1


Study Sponsor

University of Pennsylvania

Collaborators

 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor

Kurt T Barnhart, MD, MSCE, Principal Investigator, University of Pennsylvania


Verification Date

August 2016