Ectopic Pregnancy Biomarkers

NCT00194168 | Completed

• 2 other identifiers: 705016RRU002
• Study Type: observational
• Target: 1,306
• Locations: 1 country
• Sites: 3

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.

Conditions

Ectopic Pregnancy

Keywords

ectopic pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead
• Bill and Melinda Gates Foundation: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (3)

University of Southern California Women's and Children's Hospital

Los Angeles, California, 90033, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Barnhart KT, Guo W, Cary MS, Morse CB, Chung K, Takacs P, Senapati S, Sammel MD. Differences in Serum Human Chorionic Gonadotropin Rise in Early Pregnancy by Race and Value at Presentation. Obstet Gynecol. 2016 Sep;128(3):504-511. doi: 10.1097/AOG.0000000000001568.

  PMID: 27500326 DERIVED

• 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):573-582. doi: 10.1097/AOG.0b013e31820b3c61.

  PMID: 21343760 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (Plasma, Serum)

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kurt T Barnhart, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: June 1, 2000
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (3)