Ectopic Pregnancy Biomarkers

Ectopic Pregnancy Clinical Trial

Official title:

Serum Bank for Assessment of Markers of Ectopic Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194168
• Other study ID #: 705016
• Secondary ID: RRU002
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 15, 2016
• Start date: June 2000
• Est. completion date: November 2013

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1306
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Locations

Country	Name	City	State
United States	University of Southern California Women's and Children's Hospital	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Bill and Melinda Gates Foundation, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,