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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: August 15, 2016
Last verified: August 2016

September 13, 2005
August 15, 2016
June 2000
November 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00194168 on ClinicalTrials.gov Archive Site
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Ectopic Pregnancy Biomarkers
Serum Bank for Assessment of Markers of Ectopic Pregnancy
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Blood (Plasma, Serum)
Non-Probability Sample
Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice
Ectopic Pregnancy
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Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-82. doi: 10.1097/AOG.0b013e31820b3c61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1306
November 2013
November 2013   (final data collection date for primary outcome measure)

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:

Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194168
705016, RRU002
No
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University of Pennsylvania
University of Pennsylvania
  • Bill and Melinda Gates Foundation
  • National Institutes of Health (NIH)
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
University of Pennsylvania
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP