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Clinical Trials/NCT03938129
NCT03938129
Completed
Not Applicable

Improving Women's and Children's Health Via Biobanking and Electronic Registry

Mark Santillan7 sites in 1 country1,976 target enrollmentJanuary 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Mark Santillan
Enrollment
1976
Locations
7
Primary Endpoint
1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2020
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Mark Santillan
Responsible Party
Sponsor Investigator
Principal Investigator

Mark Santillan

Associate Professor

University of Iowa

Eligibility 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.

Outcomes

Primary Outcomes

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.

Study Sites (7)

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