NCT02321007

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
64mo left

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2014Sep 2031

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
16.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

17 years

First QC Date

December 3, 2014

Last Update Submit

February 10, 2026

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women delivering at term as well as women with pregnancy complications such as pre-term birth, intrauterine growth restriction, diabetes and obesity will be eligible for the study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

  • Thomas Jansson, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Kramer

CONTACT

303-724-1653anita.kramer@ucdenver.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 19, 2014

Study Start

September 1, 2014

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)