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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03938129
Acronym
iELEVATE
Enrollment
1976
Registered
2019-05-06
Start date
2020-01-07
Completion date
2022-02-28
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal-Fetal Relations, Pregnancy Related

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.

Interventions

OTHERBlood sample

1st trimester blood sample for bio-bank

OTHERUrine sample

1st trimester urine sample for bio-bank

OTHERPregnancy, maternal health, and fetal health data

Pregnancy, maternal health, and fetal health data

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Mark Santillan
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]2 yearsCreate bio-bank of maternal blood,urine and data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026