Pre-EclampsiaNCT04900207
Placental Volume, Flow, and Vascularity Study
An observational study of Pre-Eclampsia, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume, blood flow, and vascularity. This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 30 Jun 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants are pregnant adults in the first trimester of gestation who are receiving an ultrasound at one of the qualifying study sites.
Who may be able to join
- Singleton gestation
- Qualify for a first-trimester screen at the time of enrollment. Criteria for the screen include pregnancy with gestational age between 10 weeks 3 days and 13 weeks 6 days of gestation as well as a crown-rump length between 40 and 84 mm.
- Complete a first-trimester ultrasound at the qualifying M Health Fairview Maternal Fetal Medicine Clinics, which include University Riverside, Ridges, South Dale, and Health East sites
- Provide a blood sample for either completion of the first-trimester screen and/or for the completion of the research study
Who cannot join
- Multi-fetal gestation or pregnancy with major fetal congenital anomalies and/or known fetal aneuploidy
- Unwilling to complete a first-trimester ultrasound and/or unwilling to provide a serum sample
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume, blood flow, and vascularity. This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume. This information will then be used to further investigate whether placental volume, blood flow, and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound.
Read the detailed description
Preeclampsia is defined as a multi-system disorder typically characterized by hypertension, proteinuria, and/or end organ damage. Preeclampsia can develop rapidly at any time after 20 weeks gestation and into the postpartum period and can at times lead to systemic complications and even death. Preeclampsia continues to be a leading cause of maternal morbidity and mortality secondary to the development of hypertensive disorders, systemic inflammatory changes affecting the endothelium, and hemorrhagic complications. It also contributes indirectly to neonatal morbidity and mortality by leading to premature delivery. Our current ability to screen patients for the risk of developing preeclampsia relies on clinical factors as recommended by ACOG and the USPHS. At this time, if a patient is deemed high risk, our only intervention for prevention of preeclampsia is to prescribe low-dose aspirin. Being able to identify the population at higher risk for preeclampsia would allow for implementation of new management options among these persons. The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume, blood flow, and vascularity. This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume. This information will then be used to further investigate whether placental volume, blood flow, and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observed Group | Participants will be enrolled in the study at the time of their first-trimester screen (10w3d-13w6d weeks of gestation) to the time of their delivery. Collection of first-trimester 3D-volume ultrasound imaging to measure the placental volume, blood flow, and vascularity and maternal serum markers will occur over a 6-12 months period. Collection of descriptive and pregnancy outcome information will be obtained from the electronic medical records will continue through their pregnancy episode (typical 9 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Model for the Development of Preeclampsia
The primary measure for this study will be the positive predictive value of the model for the development of preeclampsia. Outcome is reported as the percent of correct predictions made by the model.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start10 Mar 2021
- Primary completion27 Oct 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Contag, MD, Principal investigator, University of Minnesota Medical School Department of Obstetrics, Gynecology, & Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900207
- Sponsor's protocol ID
- STUDY00009133
- Status last verified
- Aug 2022
- First submitted
- 26 Apr 2021
- Last updated
- 3 Aug 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Volume, Flow, and Vascularity Study
- ClinicalTrials.gov ID
- NCT04900207
- Acronym / sponsor ID
- STUDY00009133
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 May 2021 (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.
The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume, blood flow, and vascularity. This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume. This information will then be used to further investigate whether placental volume, blood flow, and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound.
Detailed description
Preeclampsia is defined as a multi-system disorder typically characterized by hypertension, proteinuria, and/or end organ damage. Preeclampsia can develop rapidly at any time after 20 weeks gestation and into the postpartum period and can at times lead to systemic complications and even death. Preeclampsia continues to be a leading cause of maternal morbidity and mortality secondary to the development of hypertensive disorders, systemic inflammatory changes affecting the endothelium, and hemorrhagic complications. It also contributes indirectly to neonatal morbidity and mortality by leading to premature delivery. Our current ability to screen patients for the risk of developing preeclampsia relies on clinical factors as recommended by ACOG and the USPHS. At this time, if a patient is deemed high risk, our only intervention for prevention of preeclampsia is to prescribe low-dose aspirin. Being able to identify the population at higher risk for preeclampsia would allow for implementation of new management options among these persons. The purpose of this preliminary study is to implement an automated and standardized computer-based method that accurately measures placental volume, blood flow, and vascularity. This will be accomplished by using the digital data obtained at the time of a first-trimester 3D image volume. This information will then be used to further investigate whether placental volume, blood flow, and vascularity can be used to predict the risk of preeclampsia in conjunction with maternal history and serum blood markers obtained at the time of their ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed Group | – | –Participants will be enrolled in the study at the time of their first-trimester screen (10w3d-13w6d weeks of gestation) to the time of their delivery. Collection of first-trimester 3D-volume ultrasound imaging to measure the placental volume, blood flow, and vascularity and maternal serum markers will occur over a 6-12 months period. Collection of descriptive and pregnancy outcome information will be obtained from the electronic medical records will continue through their pregnancy episode (typical 9 months). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants are pregnant adults in the first trimester of gestation who are receiving an ultrasound at one of the qualifying study sites.
Key inclusion criteria (4 listed)
- Singleton gestation
- Qualify for a first-trimester screen at the time of enrollment. Criteria for the screen include pregnancy with gestational age between 10 weeks 3 days and 13 weeks 6 days of gestation as well as a crown-rump length between 40 and 84 mm.
- Complete a first-trimester ultrasound at the qualifying M Health Fairview Maternal Fetal Medicine Clinics, which include University Riverside, Ridges, South Dale, and Health East sites
- Provide a blood sample for either completion of the first-trimester screen and/or for the completion of the research study
Key exclusion criteria (2 listed)
- Multi-fetal gestation or pregnancy with major fetal congenital anomalies and/or known fetal aneuploidy
- Unwilling to complete a first-trimester ultrasound and/or unwilling to provide a serum sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Value of Model for the Development of Preeclampsia
Time frame: up to 12 months
The primary measure for this study will be the positive predictive value of the model for the development of preeclampsia. Outcome is reported as the percent of correct predictions made by the model.
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 3 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
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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.
Stephen Contag, MD principal investigator
University of Minnesota Medical School Department of Obstetrics, Gynecology, & Women's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by University of Minnesota at 1 site 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 4 inclusion and 2 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Predictive Value of Model for the Development of Preeclampsia (time frame: up to 12 months). 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 3 Aug 2022.