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

• ClinicalTrials.gov Identifier: NCT03938129
• Recruitment Status: Enrolling by invitation
• First Posted: May 6, 2019
• Last Update Posted: October 22, 2020
• Sponsor: Mark Santillan
• 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
• 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

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

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