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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Maternal-Fetal Relations
• Intervention / Treatment: Other: Blood sample; Other: Urine sample; Other: Pregnancy, maternal health, and fetal health data

• Study Type: Observational
• Enrollment (Actual): 1976

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • OB Gyn Associates, PC
    • Davenport, Iowa, United States, 52807
      • The Group Obstetrics & Gynecology Specialists, PC
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
    • West Des Moines, Iowa, United States, 50266
      • West Des Moines OB GYN Associates, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
  • Wisconsin
    • Wausau, Wisconsin, United States, 55401
      • Marshfield Clinic Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman in their first trimester.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Pregnant women and their baby	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mark Santillan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Mark Santillan, PhD, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 201901749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No