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

NCT ID: NCT03938129

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1976 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2022-02-28

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.

Conditions

Pregnancy Related; Maternal-Fetal Relations

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Pregnant women and their baby

Blood sample

Intervention Type: OTHER

1st trimester blood sample for bio-bank

Urine sample

Intervention Type: OTHER

1st trimester urine sample for bio-bank

Pregnancy, maternal health, and fetal health data

Intervention Type: OTHER

Pregnancy, maternal health, and fetal health data

Interventions

Blood sample

1st trimester blood sample for bio-bank

Intervention Type: OTHER

Urine sample

1st trimester urine sample for bio-bank

Intervention Type: OTHER

Pregnancy, maternal health, and fetal health data

Pregnancy, maternal health, and fetal health data

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Mark Santillan

OTHER

Sponsor Role: lead

Responsible Party

Mark Santillan

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark Santillan, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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

West Des Moines OB GYN Associates, PC

West Des Moines, Iowa, United States

University of Minnesota

Minneapolis, Minnesota, United States

Marshfield Clinic Research Institute

Wausau, Wisconsin, United States

Countries

United States

Other Identifiers

201901749

Identifier Type: -

Identifier Source: org_study_id