Placenta DiseasesNCT03764878
MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function
An observational study of Placenta Diseases, run by Endeavor Health at 1 site in United States.
Trial summary
The objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Diseases
- What is being tested?
- functional MRI
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 1 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women at 30-34 weeks gestation who are scheduled for a cesarean delivery. For this pilot project, 10 obese (OB) women, 10 women with pregestational diabetes (PGD) and 10 women without OB or PGD will be recruited. OB is defined as prepregnancy or first trimester BMI greater than or equal to 30 kg/ m2. PGD will be defined as Type 1 or Type 2 diabetes diagnosed prior to the pregnancy or in the first trimester.
Who may be able to join
- singleton pregnancy
- planned cesarean section
Who cannot join
- non-English speaking
- fetal anomalies
- gestational diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
The objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). The investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.
Read the detailed description
In this study, we propose to utilize two novel and innovative non-invasive tools to measure placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB), have pregestational diabetes (DM) or have neither (controls). To evaluate differences in placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a method of functional magnetic resonance imaging, to measure tissue oxygenation in the placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.
To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6 FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24. Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18. Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the most abundant structural protein on the surface of lipid droplets of adipocytes.
We hypothesize that altered placental function including diminished placental oxygenation and abnormal placental transport of lipids and other metabolites will be seen in OB and DM women as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic and immunohistochemistry characteristics will be associated with in vivo findings. Our findings from this pilot study have the potential to serve as the basis of a larger study to further evaluate the potential impact of BOLD and MRS technology on our understanding of placental lipid and oxygen transport among women with obesity and pregestational diabetes as compared to women without these conditions.
- Conditions
- Placenta Diseases
- Being tested
- functional MRI
- Medical subject headings
- Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional MRIDiagnostic test
Participants will undergo a functional MRI using multiple imaging modalities.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | BMI 18.5-24.9 kg/m^2 low risk pregnancy Receives: Diagnostic Test: functional MRI | |
| Pregestational diabetes mellitus | Type 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester Receives: Diagnostic Test: functional MRI | |
| Obese | Pre-pregnancy BMI ≥ 30.0 kg/m^2 Receives: Diagnostic Test: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOLD response level in the placenta
As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta
Measured: 1 day
Secondary outcomes (2)
Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin
As measured on MRI during third trimester in the central area of the placenta
Measured: 1 day
Placenta ratio of choline to lipid
As measured on MRI during third trimester in the central area of the placenta
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start29 Nov 2018
- Primary completion20 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta DiseasesStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Plunkett, Endeavor Health
- Investigators
- Beth Plunkett, MD, MPH, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764878
- Sponsor's protocol ID
- EH18-300
- Status last verified
- May 2023
- First submitted
- 29 Nov 2018
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function
- ClinicalTrials.gov ID
- NCT03764878
- Acronym / sponsor ID
- EH18-300
- Conditions
- Placenta Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Dec 2018 (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 objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). The investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.
Detailed description
In this study, we propose to utilize two novel and innovative non-invasive tools to measure placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB), have pregestational diabetes (DM) or have neither (controls). To evaluate differences in placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a method of functional magnetic resonance imaging, to measure tissue oxygenation in the placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.
To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6 FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24. Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18. Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the most abundant structural protein on the surface of lipid droplets of adipocytes.
We hypothesize that altered placental function including diminished placental oxygenation and abnormal placental transport of lipids and other metabolites will be seen in OB and DM women as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic and immunohistochemistry characteristics will be associated with in vivo findings. Our findings from this pilot study have the potential to serve as the basis of a larger study to further evaluate the potential impact of BOLD and MRS technology on our understanding of placental lipid and oxygen transport among women with obesity and pregestational diabetes as compared to women without these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Diagnostic Test: functional MRIBMI 18.5-24.9 kg/m^2 low risk pregnancy |
| Pregestational diabetes mellitus | – | Diagnostic Test: functional MRIType 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester |
| Obese | – | Diagnostic Test: functional MRIPre-pregnancy BMI ≥ 30.0 kg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women at 30-34 weeks gestation who are scheduled for a cesarean delivery. For this pilot project, 10 obese (OB) women, 10 women with pregestational diabetes (PGD) and 10 women without OB or PGD will be recruited. OB is defined as prepregnancy or first trimester BMI greater than or equal to 30 kg/ m2. PGD will be defined as Type 1 or Type 2 diabetes diagnosed prior to the pregnancy or in the first trimester.
Key inclusion criteria (2 listed)
- singleton pregnancy
- planned cesarean section
Key exclusion criteria (3 listed)
- non-English speaking
- fetal anomalies
- gestational diabetes mellitus
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 |
|---|---|---|
| functional MRIParticipants will undergo a functional MRI using multiple imaging modalities. | Diagnostic test | Normal weight, Obese, Pregestational diabetes mellitus |
Primary outcome
Change in BOLD response level in the placenta
Time frame: 1 day
As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta
2 secondary outcomes
Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin
Time frame: 1 day
Placenta ratio of choline to lipid
Time frame: 1 day
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 18 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Beth Plunkett, MD, MPH principal investigator
Endeavor 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 Placenta Diseases, run by Endeavor Health 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 2 inclusion and 3 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 18 May 2023. 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?
Change in BOLD response level in the placenta (time frame: 1 day). 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 18 May 2023.