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

Pregnancy Related Clinical Trial

— iELEVATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938129
• Other study ID #: 201901749
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1976
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Maternal-Fetal Relations
• Pregnancy Related

Intervention

Other:
• Blood sample
1st trimester blood sample for bio-bank
• Urine sample
1st trimester urine sample for bio-bank
• Pregnancy, maternal health, and fetal health data
Pregnancy, maternal health, and fetal health data

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	OB Gyn Associates, PC	Cedar Rapids	Iowa
United States	The Group Obstetrics & Gynecology Specialists, PC	Davenport	Iowa
United States	University of Iowa	Iowa City	Iowa
United States	University of Minnesota	Minneapolis	Minnesota
United States	Marshfield Clinic Research Institute	Wausau	Wisconsin
United States	West Des Moines OB GYN Associates, PC	West Des Moines	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Mark Santillan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]	Create bio-bank of maternal blood,urine and data.	2 years