MitoQ to improve blood vessel function in preeclampsia
MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach
This will test whether MitoQ, a mitochondrial antioxidant pill, can improve blood vessel function and help prolong pregnancy in people with preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT07229261 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled interventional study will give pregnant participants with preeclampsia either MitoQ (mitoquinol mesylate) or placebo and measure vascular function, placental biomarkers, and clinical pregnancy outcomes. The protocol includes separate inpatient and outpatient cohorts covering roughly 23 to 34 weeks' gestation for singleton pregnancies, with vascular function studies and collection of patient samples before and after dosing. Investigators will compare vasodilation, markers of placental function, and pregnancy prolongation between treatment groups while analyzing clinical data and biospecimens for mitochondrial oxidative stress pathways. Positive findings would support a larger clinical trial to determine whether MitoQ can become a therapeutic option for preeclampsia.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 18–50 with a singleton pregnancy diagnosed with preeclampsia between about 23 and 34 weeks who are managed expectantly (no immediate delivery) and can consent and attend study visits.
Not a fit: People who require immediate delivery, have multiple gestations, have certain exclusionary medical conditions (for example some clotting disorders), cannot stand without assistance, or cannot attend in-person visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, MitoQ could improve placental blood flow, delay delivery, and reduce maternal and neonatal complications associated with preeclampsia.
How similar studies have performed: Preclinical and ex vivo studies, including work with mitochondrial antioxidants like MitoTempol, have improved placental microvascular vasodilation, but clinical data for MitoQ in preeclampsia remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer J McIntosh, D.O., — Medical College of Wisconsin
- Study coordinator: Jennifer McIntosh, D.O., M.S.
- Email: jmcintosh@mcw.edu
- Phone: 14148059019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.