NCT05653973RecruitingEarly phase 1
Prenatal Aspirin and Postpartum Vascular Function
Protective Mechanisms of Prenatal Aspirin Therapy on Maternal Vascular Dysfunction Following Preeclampsia
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Preeclampsia is a pregnancy disorder affecting \~5-10% of pregnancies in the United States. Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. Low dose aspirin (LDA; 75-150mg/daily) is currently the most effective and clinically accepted therapy for reducing preeclampsia prevalence in women at high risk for developing the syndrome. The purpose of this study is to interrogate the mechanisms by which LDA therapy mitigates persistent vascular dysfunction in postpartum women who have had preeclampsia. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had a history of preeclampsia. As a compliment to these measurements, they also draw blood from the subjects and isolate the inflammatory cells.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 3 Jan 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Anna Stanhewicz, PhD
- NCT number
- NCT05653973
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 3 Jan 2023 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion:
- 18 years or older,
- 12 weeks to 5 years postpartum
- and one of the following:
- women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy,
- women who had a normal pregnancy and used LDA during pregnancy,
- women who had preeclampsia and did not use LDA during pregnancy,
- women who had preeclampsia and used LDA during pregnancy.
- Exclusion:
- current daily aspirin use,
- skin diseases,
- current tobacco use,
- diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2,
- statin or other cholesterol-lowering medication,
- current antihypertensive medication,
- history of hypertension prior to pregnancy,
- history of gestational diabetes,
- current pregnancy,
- body mass index \<18.5 kg/m2,
- allergy to materials used during the experiment.(e.g. latex),
- known allergies to study drugs.
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.