Condition or disease | Intervention/treatment |
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Pregnancy Related Maternal-Fetal Relations | Other: Blood sample Other: Urine sample Other: Pregnancy, maternal health, and fetal health data |
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 7, 2020 |
Estimated Primary Completion Date : | February 28, 2022 |
Estimated Study Completion Date : | February 28, 2022 |
Group/Cohort | Intervention/treatment |
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Group 1
Pregnant women and their baby
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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
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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 |
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.
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Iowa | |
OB Gyn Associates, PC | |
Cedar Rapids, Iowa, United States, 52402 | |
The Group Obstetrics & Gynecology Specialists, PC | |
Davenport, Iowa, United States, 52807 | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
West Des Moines OB GYN Associates, PC | |
West Des Moines, Iowa, United States, 50266 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55414 | |
United States, Wisconsin | |
Marshfield Clinic Research Institute | |
Wausau, Wisconsin, United States, 55401 |
Principal Investigator: | Mark Santillan, PhD, MD | University of Iowa |
Tracking Information | |||||
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First Submitted Date | May 2, 2019 | ||||
First Posted Date | May 6, 2019 | ||||
Last Update Posted Date | May 5, 2021 | ||||
Actual Study Start Date | January 7, 2020 | ||||
Estimated Primary Completion Date | February 28, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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.
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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 |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
1st trimester maternal blood and urine sample
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Sampling Method | Non-Probability Sample | ||||
Study Population | Pregnant woman in their first trimester. | ||||
Condition |
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Intervention |
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Study Groups/Cohorts | Group 1
Pregnant women and their baby
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Enrolling by invitation | ||||
Estimated Enrollment |
10000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | February 28, 2022 | ||||
Estimated Primary Completion Date | February 28, 2022 (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. |
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Mark Santillan, University of Iowa | ||||
Study Sponsor | Mark Santillan | ||||
Collaborators | National Institutes of Health (NIH) | ||||
Investigators |
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PRS Account | University of Iowa | ||||
Verification Date | May 2021 |