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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03938129

Recruitment Status Enrolling by invitation

First Posted May 6, 2019

Last update posted May 5, 2021

Study Description

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.

  • Condition or Disease:Pregnancy Related
    Maternal-Fetal Relations
  • Intervention/Treatment: Other: Blood sample
    Other: Urine sample
    Other: Pregnancy, maternal health, and fetal health data
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 10000 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Improving Women's and Children's Health Via Biobanking and Electronic Registry
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: February 2022
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • Primary Outcome Measures: 1. 1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ] [ Time Frame: 2 years ]
    Create bio-bank of maternal blood,urine and data.
  • Biospecimen Retention: Samples With DNA

    1st trimester maternal blood and urine sample

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Pregnant woman in their first trimester.
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.

Contacts and Locations
Contacts
Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham

United States, Iowa
OB Gyn Associates, PC
Cedar Rapids

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

United States, Iowa
University of Iowa
Iowa City

United States, Iowa
West Des Moines OB GYN Associates, PC
West Des Moines

United States, Minnesota
University of Minnesota
Minneapolis

United States, Wisconsin
Marshfield Clinic Research Institute
Wausau

Sponsors and Collaborators

Mark Santillan

National Institutes of Health (NIH)

Investigators

Principal Investigator: Mark Santillan, PhD, MD University of Iowa

More Information
  • Responsible Party: Mark Santillan
  • ClinicalTrials.gov Identifier: NCT03938129 History of Changes
  • Other Study ID Numbers: 201901749
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 5, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No