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Clinical Trials/NCT02321007
NCT02321007RecruitingNot Applicable

Study of Placental Function in Healthy and Pathological Pregnancies

University of Colorado, Denver1 site in 1 country1,250 target enrollmentStarted: September 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,250
Locations
1
Primary Endpoint
Collecting, processing, and archiving human specimens from 1250 subjects

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy women delivering at term
  • Women with pregnancy complications such as:
  • pre-term birth,
  • intrauterine growth restriction,
  • diabetes, and

Exclusion Criteria

  • under stress,
  • experiencing pain of labor.
  • Pregnancies complicated by other pathologies.

Outcomes

Primary Outcomes

Collecting, processing, and archiving human specimens from 1250 subjects

Time Frame: Specimens will be stored for 50 years in repository

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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