NCT03938129

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,976 (actual)
• Sponsor: Mark Santillan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Related
• Maternal-Fetal Relations

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-07
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2019-05-06
• Last updated: 2022-05-24

Locations

7 sites across 1 country: United States