Recruiting

MitoQ

Sponsor:

Medical College of Wisconsin

Code:

NCT07229261

Conditions

Preeclampsia

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Mitoquinol Mesylate

Placebo

Study Details

Brief summary:

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.

Conditions

Preeclampsia

Pregnancy

Study ID

NCT07229261

Start date

Mar 18, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Preeclampsia with Severe Features taking Mitoquinol Mesylate

Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

placebo comparator: Preeclampsia with Severe Features taking placebo

Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive Placebo daily from enrollment until delivery.

experimental: Preeclampsia without Severe Features taking MitoQ

Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

placebo comparator: Preeclampsia without Severe Features taking placebo

Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive placebo daily from enrollment until delivery.

Interventions

Mitoquinol Mesylate

Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

Placebo

Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.

Primary outcome measure

  • Brachial Artery Flow Mediated Dilation (FMD) [ Time Frame: 1-2 times per week from enrollment until delivery, up to 10 months ]

Central Contacts and Locations

Central contacts

Jennifer McIntosh, D.O., M.S.

14148059019jmcintosh@mcw.edu

Locations

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Jennifer McIntosh

4148059019jmcintosh@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • pregnancy
  • preeclampsia
  • MitoQ
  • Mitoquinone
  • Endothelial Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-05-01.