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

M

Mark Santillan

Status

Completed

Conditions

Pregnancy Related
Maternal-Fetal Relations

Treatments

Other: Blood sample
Other: Pregnancy, maternal health, and fetal health data
Other: Urine sample

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03938129
201901749

Details and patient eligibility

About

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.

Enrollment

1,976 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,976 participants in 1 patient group

Group 1
Description:
Pregnant women and their baby
Treatment:
Other: Pregnancy, maternal health, and fetal health data
Other: Blood sample
Other: Urine sample

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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