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Improving Women's and Children's Health Via Biobanking and Electronic Registry (iELEVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938129
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Mark Santillan, University of Iowa

Tracking Information
First Submitted Date May 2, 2019
First Posted Date May 6, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date January 7, 2020
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
1st trimester maternal blood and urine sample
Sampling Method Non-Probability Sample
Study Population Pregnant woman in their first trimester.
Condition
  • Pregnancy Related
  • Maternal-Fetal Relations
Intervention
  • 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
Study Groups/Cohorts Group 1
Pregnant women and their baby
Interventions:
  • Other: Blood sample
  • Other: Urine sample
  • Other: Pregnancy, maternal health, and fetal health data
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 2, 2019)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03938129
Other Study ID Numbers 201901749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mark Santillan, University of Iowa
Study Sponsor Mark Santillan
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Mark Santillan, PhD, MD University of Iowa
PRS Account University of Iowa
Verification Date October 2020