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

• Sponsor: Mark Santillan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03938129
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 1,976
• Locations: 7
• Actual Duration (Months): 25.7
• Patients Per Site: 282.3
• Patients Per Site Per Month: 11

Study Details

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	Intervention/Treatment	Phase
Pregnancy Related; Maternal-Fetal Relations	Other: Blood sample; Other: Urine sample; Other: Pregnancy, maternal health, and fetal health data

Study Design

• Study Type: Observational
• Actual Enrollment: 1976 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: Jan 7, 2020
• Actual Primary Completion Date: Feb 28, 2022
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	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 ] [2 years]

   Create bio-bank of maternal blood,urine and data.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	OB Gyn Associates, PC	Cedar Rapids	Iowa	United States	52402
3	The Group Obstetrics & Gynecology Specialists, PC	Davenport	Iowa	United States	52807
4	University of Iowa	Iowa City	Iowa	United States	52242
5	West Des Moines OB GYN Associates, PC	West Des Moines	Iowa	United States	50266
6	University of Minnesota	Minneapolis	Minnesota	United States	55414
7	Marshfield Clinic Research Institute	Wausau	Wisconsin	United States	55401

Sponsors and Collaborators

• Mark Santillan
• National Institutes of Health (NIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Santillan, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT03938129
• Other Study ID Numbers: 201901749
• First Posted: May 6, 2019
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 24, 2022