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MitoQ to Improve Vascular Funciton in Preeclampsia

MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether MitoQ can help blood vessels widen, help the placenta work better, and allow pregnancy to last longer. It is for pregnant patients with high blood pressure that starts during pregnancy or preeclampsia, a pregnancy condition involving high blood pressure and other health problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are pregnant and age 18–50.
  • Are carrying one baby.
  • Hospital group: Have preeclampsia with severe symptoms or signs and are 23 weeks, 0 days to 33 weeks, 0 days pregnant.
  • At-home care group: Have preeclampsia without severe symptoms or signs, or high blood pressure that started during pregnancy. Are 23 weeks, 0 days to 34 weeks, 0 days pregnant.
  • Do not need to deliver the baby right away.
  • Hospital group: You and your care team plan to wait before delivery. At-home care group: You plan to receive care outside the hospital.
  • Can agree to join the study and follow a two-step instruction.
  • Speak English.

Who can't join

  • Cannot stand up from a chair without another person's help. Using a support device is allowed.
  • Have had blood clots in your arms or legs, or have a condition that makes thigh squeezing or a brief cut in blood flow unsafe, such as leg wounds.
  • Have symptoms lasting more than 6 months after severe COVID-19.
  • Have had a head injury or concussion in the past 6 months, or have a disorder of the brain or nerves.
  • Have peripheral vascular disease, which affects blood vessels outside the heart and brain.
  • Were diagnosed with a heart attack or an abnormal heartbeat in the past year.
  • Have resting blood pressure with a top number of 180 or higher, or a bottom number of 100 or higher.
  • Have another major health condition that the study doctor thinks could affect the study or your safety.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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 sites (1)

WI