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Ectopic Pregnancy Biomarkers

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ClinicalTrials.gov Identifier: NCT00194168
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.

Condition or disease
Ectopic Pregnancy

Study Design
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Study Type : Observational
Actual Enrollment : 1306 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Bank for Assessment of Markers of Ectopic Pregnancy
Study Start Date : June 2000
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Blood (Plasma, Serum)

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice
Criteria

Inclusion Criteria:

  • Reproductive-aged women
  • Currently pregnant based on serum human chorionic gonadotropin level
  • Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping

  • Final diagnosis of one of the following:

    1. Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
    2. Diagnosed ectopic pregnancy
    3. Ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00194168


Locations
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United States, California
University of Southern California Women's and Children's Hospital
Los Angeles, California, United States, 90033
United States, Florida
University of Miami
Miami, Florida, United States, 33101
United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Bill and Melinda Gates Foundation
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194168    
Other Study ID Numbers: 705016
RRU002
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
ectopic pregnancy
Additional relevant MeSH terms:
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Pregnancy, Ectopic
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Pregnancy Complications