Serum Bank for Assessment of Markers of Ectopic Pregnancy

Ectopic Pregnancy Biomarkers

Sponsors

Lead sponsor: University of Pennsylvania

Collaborator: Bill and Melinda Gates Foundation
National Institutes of Health (NIH)

Source University of Pennsylvania
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.

Overall Status Completed
Start Date June 2000
Completion Date November 2013
Primary Completion Date November 2013
Study Type Observational
Enrollment 1306
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kurt T Barnhart, MD, MSCE Principal Investigator University of Pennsylvania
Location
facility
University of Southern California Women's and Children's Hospital | Los Angeles, California, 90033, United States
University of Miami | Miami, Florida, 33101, United States
University of Pennsylvania Reproductive Research Unit | Philadelphia, Pennsylvania, 19104, United States
Location Countries

United States

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov