PreeclampsiaMAVENNCT07229261
MitoQ to Improve Vascular Funciton in Preeclampsia
A study testing Mitoquinol Mesylate in people with Preeclampsia and Pregnancy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia, Pregnancy
- What is being tested?
- Mitoquinol Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Jennifer McIntosh, 4148059019, jmcintosh@mcw.edu
About this study
Official title: MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach
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.
Read the detailed description
Preeclampsia (PreE) impacts ~10% of pregnancies and has severe outcomes both during and after pregnancy. It is a leading cause of pregnancy-related deaths and has long term cardiovascular consequences for maternal and child health. Despite advances in the understanding of preeclampsia over the past 50 years, the underlying unifying mechanism causing preeclampsia remains elusive. This critical gap not only encompasses lack of understanding of the pathophysiology, but it also includes a lack of therapeutics for prevention or treatment. Success in this study could translate into a clinical trial that could finally offer a treatment for PreE.
The investigators have recently demonstrated that endothelial function in the human placental microcirculation is impacted by excess reactive oxygen and nitrogen species (ROS, RNS) from the mitochondria (MT), which in preeclampsia, impairs vasodilation. Excess ROS causes decreased nitric oxide (NO) bioavailability, increased lipid peroxidation, uncoupled eNOS, peroxynitrite, and exacerbates MT dysfunction and MT DNA damage via alterations in NO. Microvascular function can be improved by mechanisms that rebalance the oxidative stress response. The investigators have shown that MitoTempol, a MT antioxidant, improves vasodilation. Moreover, the investigators have shown that a major part of the cycle of excessive oxidative stress is caused by MT DNA damage and subsequent activation of toll like receptor 9 (TLR9), and that inhibiting TLR9 prevents this dysfunction. The finding that MT antioxidants given ex-vivo can reverse placental vascular damage after delivery gives promise that treatment of patients during pregnancy could restore vasodilation and allow for safer prolongation of pregnancy.
MitoQ (Mitoquinol Mesylate) is a nutritional supplement, and mitochondrial antioxidant. MitoQ has been extensively studied pre- clinically in cell-culture, and pregnant mouse, rat, and sheep models of PreE or oxidative stress and demonstrated beneficial fetal results. It has been used in clinical trials for heart failure, hepatitis C, Parkinson's, and multiple sclerosis with doses from 10mg to 80mg per day.
Overall Hypothesis: The investigators hypothesize that MitoQ (Mitoquinol Mesylate)-treated preeclampsia and/or gHTN patients will have improved brachial artery flow-mediated dilation (FMD) and laser Doppler flowmetry assessments of the cutaneous microvasculature, and that placental endothelial function in micro-vessels and placental pathology will be improved in treated patients. To demonstrate this, the investigators will enroll two pilot human cohorts- one of admitted patients with preeclampsia with severe features who will either continue standard in-patient clinical care or be supplemented daily with MitoQ (Mitoquinol Mesylate) and a second outpatient cohort of patients with preeclampsia without severe features or gHTN who will received standard outpatient care or be supplemented daily with MitoQ
Aim: Test whether with MitoQ (Mitoquinol Mesylate) treatment in gHTN/preeclamptic patients improves endothelial function Hypothesis: MitoQ (Mitoquinol Mesylate)-treated patients will have improved brachial artery FMD and laser Doppler flowmetry assessments of the cutaneous microvasculature and placental endothelial function in micro-vessels and placental pathology will be improved in treated patients.
- Conditions
- Preeclampsia, Pregnancy
- Being tested
- Mitoquinol Mesylate, Placebo
- Keywords
- pregnancy, preeclampsia, MitoQ, Mitoquinone, Endothelial Function
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoquinol MesylateDietary supplement
Patients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.
PlaceboOther
Patients randomized to the placebo groups will take 1 placebo capsule daily until delivery.
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia with Severe Features taking Mitoquinol Mesylate | Experimental | 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. Receives: Dietary Supplement: Mitoquinol Mesylate |
| Preeclampsia with Severe Features taking placebo | Placebo comparator | Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive Placebo daily from enrollment until delivery. Receives: Other: Placebo |
| Preeclampsia without Severe Features or Gestational Hypertension taking MitoQ | Experimental | Patients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery. Receives: Dietary Supplement: Mitoquinol Mesylate |
| Preeclampsia without Severe Features or Gestational Hypertension taking placebo | Placebo comparator | Patients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive placebo daily from enrollment until delivery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Flow Mediated Dilation (FMD)
We will measure brachial artery vascular health in the arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
Measured: 1-2 times per week from enrollment until delivery, up to 10 months
Secondary outcomes (6)
Cutaneous Microvascular Function
Laser Doppler Flowmetry (LDF) will measure blood flow flux during local skin heating to examine microvessel vasodilation
Measured: 1-2 times per week From enrollment until delivery, up to to months.
Placental Microvascular Function
After delivery, placental vessels will be isolated from the placenta and a videomicroscopy technique will be used to evaluate flow-mediated dilation in vessels from placebo and MitoQ treated pregnancies.
Measured: At Delivery
Time from Enrollment to Delivery
Time from diagnosis and initiation of MitoQ or placebo to delivery
Measured: Time in days from enrollment to delivery, up to 10 months
Blood Draw
We will collect blood each week. The blood draw analysis may include but will not be limited to examining sFlt:PlGF ratio, plasma redox and bioenergetic analyses.
Measured: Weekly from enrollment until Delivery, up to 10 months
Maternal Preeclampsia Severity
A composite outcome of Maternal Severity of preeclampsia will be assessed and include laboratory, blood pressure, and ultrasound data relevant to preeclampsia
Measured: From enrollment until delivery, up to 10 months
Composite Neonatal Delivery Outcome
A composite outcome of neonatal delivery information including (but not limited to): cord blood, gestational age, weight, APGARs
Measured: Collected from delivery until hospital discharge; up to 1 week after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start18 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Jennifer McIntosh, Medical College of Wisconsin
- Investigators
- Jennifer J McIntosh, D.O.,, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229261
- Sponsor's protocol ID
- PRO00056100
- Acronym
- MAVEN
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses as well as related results will also be shared. The rationale for sharing only cleaned data is to foster ease of data reuse. The final dataset will include clinical data procured from demographic and relevant medical record information from participants. We will share de-identified individual-participant level (IPD) data. Appropriate de-identification measures will be utilized from IRB approved protocols and informed consents.
Publications
Vangrieken P, Al-Nasiry S, Bast A, Leermakers PA, Tulen CBM, Schiffers PMH, van Schooten FJ, Remels AHV. Placental Mitochondrial Abnormalities in Preeclampsia. Reprod Sci. 2021 Aug;28(8):2186-2199. doi: 10.1007/s43032-021-00464-y. Epub 2021 Feb 1.
PubMed 33523425Chekir C, Nakatsuka M, Noguchi S, Konishi H, Kamada Y, Sasaki A, Hao L, Hiramatsu Y. Accumulation of advanced glycation end products in women with preeclampsia: possible involvement of placental oxidative and nitrative stress. Placenta. 2006 Feb-Mar;27(2-3):225-33. doi: 10.1016/j.placenta.2005.02.016. Epub 2005 Apr 22.
PubMed 16338468Zsengeller ZK, Rajakumar A, Hunter JT, Salahuddin S, Rana S, Stillman IE, Ananth Karumanchi S. Trophoblast mitochondrial function is impaired in preeclampsia and correlates negatively with the expression of soluble fms-like tyrosine kinase 1. Pregnancy Hypertens. 2016 Oct;6(4):313-319. doi: 10.1016/j.preghy.2016.06.004. Epub 2016 Jun 30.
PubMed 27939475Opichka MA, Livergood MC, Balapattabi K, Ritter ML, Brozoski DT, Wackman KK, Lu KT, Kozak KN, Wells C, Fogo AB, Gibson-Corley KN, Kwitek AE, Sigmund CD, McIntosh JJ, Grobe JL. Mitochondrial-targeted antioxidant attenuates preeclampsia-like phenotypes induced by syncytiotrophoblast-specific Galphaq signaling. Sci Adv. 2023 Dec;9(48):eadg8118. doi: 10.1126/sciadv.adg8118. Epub 2023 Dec 1.
PubMed 38039359Oyewole AO, Birch-Machin MA. Mitochondria-targeted antioxidants. FASEB J. 2015 Dec;29(12):4766-71. doi: 10.1096/fj.15-275404. Epub 2015 Aug 7.
PubMed 26253366Vaka R, Deer E, LaMarca B. Is Mitochondrial Oxidative Stress a Viable Therapeutic Target in Preeclampsia? Antioxidants (Basel). 2022 Jan 22;11(2):210. doi: 10.3390/antiox11020210.
PubMed 35204094Teran E, Hernandez I, Nieto B, Tavara R, Ocampo JE, Calle A. Coenzyme Q10 supplementation during pregnancy reduces the risk of pre-eclampsia. Int J Gynaecol Obstet. 2009 Apr;105(1):43-5. doi: 10.1016/j.ijgo.2008.11.033. Epub 2009 Jan 19.
PubMed 19154996Weissgerber TL, Milic NM, Milin-Lazovic JS, Garovic VD. Impaired Flow-Mediated Dilation Before, During, and After Preeclampsia: A Systematic Review and Meta-Analysis. Hypertension. 2016 Feb;67(2):415-23. doi: 10.1161/HYPERTENSIONAHA.115.06554. Epub 2015 Dec 28.
PubMed 26711737Stanhewicz AE, Nuckols VR, Pierce GL. Maternal microvascular dysfunction during preeclamptic pregnancy. Clin Sci (Lond). 2021 May 14;135(9):1083-1101. doi: 10.1042/CS20200894.
PubMed 33960392Sanchez-Aranguren LC, Prada CE, Riano-Medina CE, Lopez M. Endothelial dysfunction and preeclampsia: role of oxidative stress. Front Physiol. 2014 Oct 10;5:372. doi: 10.3389/fphys.2014.00372. eCollection 2014.
PubMed 25346691
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitoQ (Mitoquinol Mesylate) to Ameliorate Vascular Function in Preeclampsia: a Novel Approach
- ClinicalTrials.gov ID
- NCT07229261
- Acronym / sponsor ID
- MAVEN / PRO00056100
- Conditions
- Preeclampsia, Pregnancy
- Keywords
- pregnancy, preeclampsia, MitoQ, Mitoquinone, Endothelial Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia (PreE) impacts ~10% of pregnancies and has severe outcomes both during and after pregnancy. It is a leading cause of pregnancy-related deaths and has long term cardiovascular consequences for maternal and child health. Despite advances in the understanding of preeclampsia over the past 50 years, the underlying unifying mechanism causing preeclampsia remains elusive. This critical gap not only encompasses lack of understanding of the pathophysiology, but it also includes a lack of therapeutics for prevention or treatment. Success in this study could translate into a clinical trial that could finally offer a treatment for PreE.
The investigators have recently demonstrated that endothelial function in the human placental microcirculation is impacted by excess reactive oxygen and nitrogen species (ROS, RNS) from the mitochondria (MT), which in preeclampsia, impairs vasodilation. Excess ROS causes decreased nitric oxide (NO) bioavailability, increased lipid peroxidation, uncoupled eNOS, peroxynitrite, and exacerbates MT dysfunction and MT DNA damage via alterations in NO. Microvascular function can be improved by mechanisms that rebalance the oxidative stress response. The investigators have shown that MitoTempol, a MT antioxidant, improves vasodilation. Moreover, the investigators have shown that a major part of the cycle of excessive oxidative stress is caused by MT DNA damage and subsequent activation of toll like receptor 9 (TLR9), and that inhibiting TLR9 prevents this dysfunction. The finding that MT antioxidants given ex-vivo can reverse placental vascular damage after delivery gives promise that treatment of patients during pregnancy could restore vasodilation and allow for safer prolongation of pregnancy.
MitoQ (Mitoquinol Mesylate) is a nutritional supplement, and mitochondrial antioxidant. MitoQ has been extensively studied pre- clinically in cell-culture, and pregnant mouse, rat, and sheep models of PreE or oxidative stress and demonstrated beneficial fetal results. It has been used in clinical trials for heart failure, hepatitis C, Parkinson's, and multiple sclerosis with doses from 10mg to 80mg per day.
Overall Hypothesis: The investigators hypothesize that MitoQ (Mitoquinol Mesylate)-treated preeclampsia and/or gHTN patients will have improved brachial artery flow-mediated dilation (FMD) and laser Doppler flowmetry assessments of the cutaneous microvasculature, and that placental endothelial function in micro-vessels and placental pathology will be improved in treated patients. To demonstrate this, the investigators will enroll two pilot human cohorts- one of admitted patients with preeclampsia with severe features who will either continue standard in-patient clinical care or be supplemented daily with MitoQ (Mitoquinol Mesylate) and a second outpatient cohort of patients with preeclampsia without severe features or gHTN who will received standard outpatient care or be supplemented daily with MitoQ
Aim: Test whether with MitoQ (Mitoquinol Mesylate) treatment in gHTN/preeclamptic patients improves endothelial function Hypothesis: MitoQ (Mitoquinol Mesylate)-treated patients will have improved brachial artery FMD and laser Doppler flowmetry assessments of the cutaneous microvasculature and placental endothelial function in micro-vessels and placental pathology will be improved in treated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia with Severe Features taking Mitoquinol Mesylate | Experimental | Dietary Supplement: Mitoquinol MesylatePatients 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. |
| Preeclampsia with Severe Features taking placebo | Placebo comparator | Other: PlaceboPatients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive Placebo daily from enrollment until delivery. |
| Preeclampsia without Severe Features or Gestational Hypertension taking MitoQ | Experimental | Dietary Supplement: Mitoquinol MesylatePatients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery. |
| Preeclampsia without Severe Features or Gestational Hypertension taking placebo | Placebo comparator | Other: PlaceboPatients allocated to this arm will be out-patients who have gestational hypertension or preeclampsia without severe features. They will receive placebo daily from enrollment until delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Inpatient Cohort
- Outpatient Cohort
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoquinol MesylatePatients randomized to the intervention will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery. | Dietary supplement | Preeclampsia with Severe Features taking Mitoquinol Mesylate, Preeclampsia without Severe Features or Gestational Hypertension taking MitoQ |
| PlaceboPatients randomized to the placebo groups will take 1 placebo capsule daily until delivery. | Other | Preeclampsia with Severe Features taking placebo, Preeclampsia without Severe Features or Gestational Hypertension taking placebo |
Primary outcome
Brachial Artery Flow Mediated Dilation (FMD)
Time frame: 1-2 times per week from enrollment until delivery, up to 10 months
We will measure brachial artery vascular health in the arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
6 secondary outcomes
Cutaneous Microvascular Function
Time frame: 1-2 times per week From enrollment until delivery, up to to months.
Placental Microvascular Function
Time frame: At Delivery
Time from Enrollment to Delivery
Time frame: Time in days from enrollment to delivery, up to 10 months
Blood Draw
Time frame: Weekly from enrollment until Delivery, up to 10 months
Maternal Preeclampsia Severity
Time frame: From enrollment until delivery, up to 10 months
Composite Neonatal Delivery Outcome
Time frame: Collected from delivery until hospital discharge; up to 1 week after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 33523425Vangrieken P, Al-Nasiry S, Bast A, Leermakers PA, Tulen CBM, Schiffers PMH, van Schooten FJ, Remels AHV. Placental Mitochondrial Abnormalities in Preeclampsia. Reprod Sci. 2021 Aug;28(8):2186-2199. doi: 10.1007/s43032-021-00464-y. Epub 2021 Feb 1.
- Background: PubMed 16338468Chekir C, Nakatsuka M, Noguchi S, Konishi H, Kamada Y, Sasaki A, Hao L, Hiramatsu Y. Accumulation of advanced glycation end products in women with preeclampsia: possible involvement of placental oxidative and nitrative stress. Placenta. 2006 Feb-Mar;27(2-3):225-33. doi: 10.1016/j.placenta.2005.02.016. Epub 2005 Apr 22.
- Background: PubMed 27939475Zsengeller ZK, Rajakumar A, Hunter JT, Salahuddin S, Rana S, Stillman IE, Ananth Karumanchi S. Trophoblast mitochondrial function is impaired in preeclampsia and correlates negatively with the expression of soluble fms-like tyrosine kinase 1. Pregnancy Hypertens. 2016 Oct;6(4):313-319. doi: 10.1016/j.preghy.2016.06.004. Epub 2016 Jun 30.
- Background: PubMed 38039359Opichka MA, Livergood MC, Balapattabi K, Ritter ML, Brozoski DT, Wackman KK, Lu KT, Kozak KN, Wells C, Fogo AB, Gibson-Corley KN, Kwitek AE, Sigmund CD, McIntosh JJ, Grobe JL. Mitochondrial-targeted antioxidant attenuates preeclampsia-like phenotypes induced by syncytiotrophoblast-specific Galphaq signaling. Sci Adv. 2023 Dec;9(48):eadg8118. doi: 10.1126/sciadv.adg8118. Epub 2023 Dec 1.
- Background: PubMed 26253366Oyewole AO, Birch-Machin MA. Mitochondria-targeted antioxidants. FASEB J. 2015 Dec;29(12):4766-71. doi: 10.1096/fj.15-275404. Epub 2015 Aug 7.
- Background: PubMed 35204094Vaka R, Deer E, LaMarca B. Is Mitochondrial Oxidative Stress a Viable Therapeutic Target in Preeclampsia? Antioxidants (Basel). 2022 Jan 22;11(2):210. doi: 10.3390/antiox11020210.
- Background: PubMed 19154996Teran E, Hernandez I, Nieto B, Tavara R, Ocampo JE, Calle A. Coenzyme Q10 supplementation during pregnancy reduces the risk of pre-eclampsia. Int J Gynaecol Obstet. 2009 Apr;105(1):43-5. doi: 10.1016/j.ijgo.2008.11.033. Epub 2009 Jan 19.
- Background: PubMed 26711737Weissgerber TL, Milic NM, Milin-Lazovic JS, Garovic VD. Impaired Flow-Mediated Dilation Before, During, and After Preeclampsia: A Systematic Review and Meta-Analysis. Hypertension. 2016 Feb;67(2):415-23. doi: 10.1161/HYPERTENSIONAHA.115.06554. Epub 2015 Dec 28.
- Background: PubMed 33960392Stanhewicz AE, Nuckols VR, Pierce GL. Maternal microvascular dysfunction during preeclamptic pregnancy. Clin Sci (Lond). 2021 May 14;135(9):1083-1101. doi: 10.1042/CS20200894.
- Background: PubMed 25346691Sanchez-Aranguren LC, Prada CE, Riano-Medina CE, Lopez M. Endothelial dysfunction and preeclampsia: role of oxidative stress. Front Physiol. 2014 Oct 10;5:372. doi: 10.3389/fphys.2014.00372. eCollection 2014.
- Individual participant dataSharing planned: Yes. The cleaned, item-level spreadsheet data for all variables will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses as well as related results will also be shared. The rationale for sharing only cleaned data is to foster ease of data reuse. The final dataset will include clinical data procured from demographic and relevant medical record information from participants. We will share de-identified individual-participant level (IPD) data. Appropriate de-identification measures will be utilized from IRB approved protocols and informed consents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer J McIntosh, D.O., principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoquinol Mesylate in people with Preeclampsia and Pregnancy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer McIntosh, D.O., M.S. (14148059019, jmcintosh@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Flow Mediated Dilation (FMD) (time frame: 1-2 times per week from enrollment until delivery, up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229261, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.