Clinical trial NCT03938129: Improving Women's and Children's Health Via Biobanking and Electronic Registry
Official title: Improving Women's and Children's Health Via Biobanking and Electronic Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Maternal-Fetal Relations
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-05-06
Enrollment: 1976
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman in their first trimester.

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.


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.

Primary outcomes:
measure: 1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cedar Rapids
country: United States
facility: OB Gyn Associates, PC
state: Iowa
city: Davenport
country: United States
facility: The Group Obstetrics & Gynecology Specialists, PC
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: West Des Moines
country: United States
facility: West Des Moines OB GYN Associates, PC
state: Iowa
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Wausau
country: United States
facility: Marshfield Clinic Research Institute
state: Wisconsin
Study officials:
affiliation: University of Iowa
name: Mark Santillan, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: