NCT07229261 · Medical College of Wisconsin
MitoQ to Improve Vascular Funciton in Preeclampsia
(MAVEN)
What this study is about
Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage.
View original scientific description
Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage. Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve placental function, and therefore promote pregnancy prolongation in patients with preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with preeclampsia could translate into a viable therapeutic option.
Interventions
DIETARY_SUPPLEMENT
Mitoquinol Mesylate
Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
OTHER
Placebo
Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.
Primary outcome measures
Brachial Artery Flow Mediated Dilation (FMD)
Time frame: 1-2 times per week from enrollment until delivery, up to 10 months
We will measure brachial artery vascular health in the arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Inpatient Cohort
- pregnant patients with a clinical diagnosis of preeclampsia with severe features
- gestational age between 23+0 and 32+0 weeks' gestation
- singleton pregnancy
- age 18-50 years old
- No indication for immediate delivery (e.g. the patient and their physician team have planned expectant management of preeclampsia with severe features
- Able to consent and follow a 2-step commend
- English speaking
- Outpatient Cohort
- Pregnant patients with a clinical diagnosis of preeclampsia without severe features
- gestational age between 23+0 and 34+0 weeks' gestation
- singleton pregnancy
- age 18-50 years old
- No indication for immediate delivery
- Planned outpatient management of preeclampsia
- Able to consent and follow a 2-step commend
- English speaking
Exclusion criteria
- • Unable to stand from chair without physical assistance from another person (able to use assistive device).
- History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
- Chronic lasting symptoms (\> 6 months) of severe COVID-19 (i.e., hospitalization)
- History of head trauma or concussion within the past 6 months
- Comorbid neurological disorder
- Peripheral vascular disease
- Diagnosed myocardial infarction or arrhythmia in the previous year
- Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
- Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
Where
- Milwaukee, Wisconsin
Collaborators
Bill and Melinda Gates Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations