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NCT07229261
MitoQ to Improve Vascular Funciton in Preeclampsia
Conditions: Preeclampsia, Pregnancy
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Medical College of Wisconsin
Location: Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin
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 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.
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
Source: ClinicalTrials.gov (NCT07229261). StuddyBuddy aggregates publicly available trial information.