NCT01104454

Brief Summary

The purpose of this study is to standardize methods in collecting and processing placenta, umbilical cord and cord blood samples. Samples will be used to determine potential differences between normal weight, overweight and obese individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

April 14, 2010

Last Update Submit

December 18, 2023

Conditions

Healthy

Keywords

healthy pregnant women

Outcome Measures

Primary Outcomes (1)

  • Placenta, cord blood and umbilical analyses

    at delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women who are at least 7 months pregnant

You may qualify if:

  • at least 7 months pregnant
  • years of age or older

You may not qualify if:

  • underweight (BMI\<18.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • Saben J, Zhong Y, Gomez-Acevedo H, Thakali KM, Borengasser SJ, Andres A, Shankar K. Early growth response protein-1 mediates lipotoxicity-associated placental inflammation: role in maternal obesity. Am J Physiol Endocrinol Metab. 2013 Jul 1;305(1):E1-14. doi: 10.1152/ajpendo.00076.2013. Epub 2013 Apr 30.

    PMID: 23632636DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

placenta, umbilical cord and cord blood

Study Officials

  • Aline Andres, Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 15, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2012

Study Completion

August 7, 2019

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)