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

Completed

• Conditions: Pregnancy Related; Maternal-Fetal Relations
• Interventions: Other: Blood sample; Other: Urine sample; Other: Pregnancy, maternal health, and fetal health data

• Registration Number: NCT03938129
• Lead Sponsor: Mark Santillan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2020-01-07
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1976

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Blood sample	Pregnant women and their baby
Group 1	Pregnancy, maternal health, and fetal health data	Pregnant women and their baby
Group 1	Urine sample	Pregnant women and their baby

Primary Outcome Measures

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

Trial Locations

Locations (7)

West Des Moines OB GYN Associates, PC; 🇺🇸 West Des Moines, Iowa, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

The Group Obstetrics & Gynecology Specialists, PC; 🇺🇸 Davenport, Iowa, United States

Marshfield Clinic Research Institute; 🇺🇸 Wausau, Wisconsin, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

OB Gyn Associates, PC; 🇺🇸 Cedar Rapids, Iowa, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States