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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Pregnancy

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