What this study is
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 gestational hypertension (gHTN) and/or preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with gHTN and/or preeclampsia could translate into a viable therapeutic option.
What's being tested
- Mitoquinol Mesylate
Intervention · DIETARY SUPPLEMENT
Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
- Placebo
Intervention · OTHER
Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.
Study details
- Official title
- MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach
- Sponsor
- Medical College of Wisconsin
- Conditions
- Preeclampsia · Pregnancy
- Enrolling
- 80 people
- Starts
- 2026-03-18
- Est. completion
- 2027-09-30
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Inpatient Cohort
- Pregnant patients with a clinical diagnosis of preeclampsia with severe features
- Gestational age between 23+0 and 33+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 or gestational hypertension
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openFroedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Jennifer McIntosh · Contact4148059019jmcintosh@mcw.edu
Recruiting
Study team
Sponsor
Medical College of Wisconsin
Study ID PRO00056100
Principal investigator
Jennifer J McIntosh, D.O.,
Medical College of Wisconsin
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.