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

NCT03938129 | Completed

• 1 other identifier: 201901749
• Study Type: observational
• Target: 1,976
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]

  Create bio-bank of maternal blood,urine and data.

  2 years

Study Arms (1)

Group 1

Pregnant women and their baby

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

Interventions

Blood sample OTHER

1st trimester blood sample for bio-bank

Group 1

Urine sample OTHER

1st trimester urine sample for bio-bank

Group 1

Pregnancy, maternal health, and fetal health data OTHER

Pregnancy, maternal health, and fetal health data

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman in their first trimester.

You may qualify if:

• Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate

You may not qualify if:

• Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.

Sponsors & Collaborators

• Mark Santillan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

OB Gyn Associates, PC

Cedar Rapids, Iowa, 52402, United States

Location

The Group Obstetrics & Gynecology Specialists, PC

Davenport, Iowa, 52807, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

West Des Moines OB GYN Associates, PC

West Des Moines, Iowa, 50266, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Marshfield Clinic Research Institute

Wausau, Wisconsin, 55401, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1st trimester maternal blood and urine sample

MeSH Terms

Interventions

Blood Specimen Collection; Pregnancy; Maternal Health

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Women's Health; Health; Population Characteristics

Study Officials

• Mark Santillan, PhD, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: January 7, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)