Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paroxetine Hydrochloride, Ascorbic acid (Vitamin C).
- Who it may be relevant to
- Registry conditions: Preeclampsia, Endothelial Function. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia
Overview
Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.
Interventions
- Drug Paroxetine Hydrochloride
Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis. - Drug Ascorbic acid (Vitamin C)
Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.
Primary outcome measures
- Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry [Time frame: at the study visit, an average of 4 hours]
- Nitric oxide-dependent dilation response measured by laser-Doppler flowmetry [Time frame: at the study visit, an average of 4 hours]
Eligibility criteria
Inclusion criteria
- 18-24 years old,
- 12 weeks - 5 years post pregnancy
- one of the following:
- history of a normal pregnancy with a current diagnosis of depression,
- history of a normal pregnancy without a current diagnosis of depression,
- history of a preeclamptic pregnancy with a current diagnosis of depression
- history of preeclamptic pregnancy without a current diagnosis of depression.
Exclusion criteria
- history of cardiovascular, metabolic, and/or skin diseases
- current or history of tobacco/nicotine/ e-cigarette use
- history of gestational diabetes
- current antihypertensive or cholesterol-lowering medication
- currently pregnant
- allergy to materials used during the experiment (e.g. latex),
- known allergy to study drugs
- currently using SSRI medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT07715669 · 202605218 · 26BCDA1622718