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Ectopic Pregnancy Biomarkers

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194168
First received: September 13, 2005
Last updated: March 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Ectopic Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Bank for Assessment of Markers of Ectopic Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Biospecimen Retention:   Samples With DNA

Blood (Plasma, Serum)


Estimated Enrollment: 2000
Study Start Date: June 2000
Study Completion Date: June 2012
  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194168

Locations
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
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194168     History of Changes
Other Study ID Numbers: 705016, RRU002
Study First Received: September 13, 2005
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
ectopic pregnancy

Additional relevant MeSH terms:
Pregnancy, Ectopic
Cardiac Complexes, Premature
Pregnancy Complications
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013