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OpenTrials
Completed

NCT Number: NCT03938129

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

1st trimester blood sample for bio-bank

Urine sample

Other

1st trimester urine sample for bio-bank

Pregnancy, maternal health, and fetal health data

Other

Pregnancy, maternal health, and fetal health data

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mark Santillan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: iELEVATE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 6, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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