Pregnancy RelatediELEVATENCT03938129
Improving Women's and Children's Health Via Biobanking and Electronic Registry
An observational study of Pregnancy Related and Maternal-Fetal Relations, run by Mark Santillan at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Maternal-Fetal Relations
- What is being tested?
- Blood sample, Urine sample and Pregnancy, maternal health, and fetal health data
- How many people
- 1,976 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Jan 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant woman in their first trimester.
Who may be able to join
- Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate
Who cannot join
- Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
OB Gyn Associates, PC
Cedar Rapids, Iowa, 52402
The Group Obstetrics & Gynecology Specialists, PC
Davenport, Iowa, 52807
University of Iowa
Iowa City, Iowa, 52242
University of Minnesota
Minneapolis, Minnesota, 55414
Marshfield Clinic Research Institute
Wausau, Wisconsin, 55401
West Des Moines OB GYN Associates, PC
West Des Moines, Iowa, 50266
About this study
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.
- Conditions
- Pregnancy Related, Maternal-Fetal Relations
- Being tested
- Blood sample, Urine sample, Pregnancy, maternal health, and fetal health data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
1st trimester blood sample for bio-bank
Urine sampleOther
1st trimester urine sample for bio-bank
Pregnancy, maternal health, and fetal health dataOther
Pregnancy, maternal health, and fetal health data
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnant women and their baby Receives: Other: Blood sample; Other: Urine sample; Other: Pregnancy, maternal health, and fetal health data |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ]
Create bio-bank of maternal blood,urine and data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start7 Jan 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,976 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Santillan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Mark Santillan, University of Iowa
- Investigators
- Mark Santillan, PhD, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938129
- Sponsor's protocol ID
- 201901749
- Acronym
- iELEVATE
- Status last verified
- May 2022
- First submitted
- 2 May 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Women's and Children's Health Via Biobanking and Electronic Registry
- ClinicalTrials.gov ID
- NCT03938129
- Acronym / sponsor ID
- iELEVATE / 201901749
- Conditions
- Pregnancy Related, Maternal-Fetal Relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,976 participants (actual)
- Lead sponsor
- Mark SantillanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Blood sample, Other: Urine sample, Other: Pregnancy, maternal health, and fetal health dataPregnant women and their baby |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant woman in their first trimester.
Key inclusion criteria (1 listed)
- Pregnant women in their first trimester (less than 14 weeks) and have the capacity to provide informed consent are eligible to participate
Key exclusion criteria (1 listed)
- Under 18 years old, known non-viable pregnancy at time of consent,inability to provide informed consent and diagnosis of a known infectious disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample1st trimester blood sample for bio-bank | Other | Group 1 |
| Urine sample1st trimester urine sample for bio-bank | Other | Group 1 |
| Pregnancy, maternal health, and fetal health dataPregnancy, maternal health, and fetal health data | Other | Group 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Santillan, PhD, MD principal investigator
University of Iowa
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Maternal-Fetal Relations, run by Mark Santillan at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Number of Participants and Controls Enrolled in Biobank [ Time Frame: 2 years ] (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.