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NCT02321007 Clinical Trial

Study of Placental Function in Healthy and Pathological Pregnancies

Pregnancy Clinical Trial

Official title:
Study of Placental Function in Healthy and Pathological Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02321007
Other study ID # 14-1073
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2014
Est. completion date September 2031

Study information
Verified date November 2023
Source University of Colorado, Denver
Contact Anita Kramer
Phone 303-724-1653
Email anita.kramer@ucdenver.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 1250
Est. completion date September 2031
Est. primary completion date September 2031
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy women delivering at term - Women with pregnancy complications such as: - pre-term birth, - intrauterine growth restriction, - diabetes, and - obesity. Exclusion Criteria: - Women: - under stress, - experiencing pain of labor. - Pregnancies complicated by other pathologies.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collecting, processing, and archiving human specimens from 1250 subjects Human placental tissue, umbilical cord blood, and maternal blood samples will be collected from pregnant women at the time of their delivery. The samples will be used to enhance understanding of the role of the placenta in the development of pregnancy complications and in programming of adult disease. Specimens will be stored for 50 years in repository
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