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Improving Women's and Children's Health Via Biobanking and Electronic Registry (iELEVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938129
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Mark Santillan, University of Iowa

Brief Summary:
Pregnancy related diseases and exposures in pregnancy are known risk factors for future disease. For example, women with a history of preeclampsia (a hypertensive disorder in pregnancy) and children born to these women are at increased risk of cardiovascular disease later in life. Yet, the mechanisms by which these long term health risks occur are unknown. Clearly, this presents a significant public health hazard as preventative and therapeutic interventions to block these pregnancy related diseases are limited. Current barriers to studying these long-term mechanisms in existing cohorts include 1) lack of paired long-term mother-child data, 2) lack of uniformly collected biosamples and 3) challenges in integrating data from multiple sources and institutions. In particular, data and biosample collection from rural and minority populations present significant challenges. The objective of the iELEVATE proposal is to expand and diversify a current biobank to accelerate long-term translational mechanistic and outcomes research in the vulnerable pregnancy population. We will accomplish this by establishing a widely available biorepository that will collect a first trimester blood and urine sample from pregnant women with a clinical data warehouse and e-registry to support long-term prospective cohort studies.

Condition or disease Intervention/treatment
Pregnancy Related Maternal-Fetal Relations Other: Blood sample Other: Urine sample Other: Pregnancy, maternal health, and fetal health data

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Improving Women's and Children's Health Via Biobanking and Electronic Registry
Actual Study Start Date : January 7, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Pregnant women and their baby
Other: Blood sample
1st trimester blood sample for bio-bank

Other: Urine sample
1st trimester urine sample for bio-bank

Other: Pregnancy, maternal health, and fetal health data
Pregnancy, maternal health, and fetal health data




Primary Outcome Measures :
  1. 1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ] [ Time Frame: 2 years ]
    Create bio-bank of maternal blood,urine and data.


Biospecimen Retention:   Samples With DNA
1st trimester maternal blood and urine sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant woman in their first trimester.
Criteria

Inclusion Criteria:

Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate

Exclusion Criteria:

Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938129


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Iowa
OB Gyn Associates, PC
Cedar Rapids, Iowa, United States, 52402
The Group Obstetrics & Gynecology Specialists, PC
Davenport, Iowa, United States, 52807
University of Iowa
Iowa City, Iowa, United States, 52242
West Des Moines OB GYN Associates, PC
West Des Moines, Iowa, United States, 50266
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Wisconsin
Marshfield Clinic Research Institute
Wausau, Wisconsin, United States, 55401
Sponsors and Collaborators
Mark Santillan
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Mark Santillan, PhD, MD University of Iowa
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Responsible Party: Mark Santillan, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03938129    
Other Study ID Numbers: 201901749
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No