Prenatal Aspirin and Postpartum Vascular Function

RECRUITING

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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.

Conditions:

🦠 Preeclampsia 🦠 Microvascular Function

🗓️ Study Start (Actual) 3 January 2023

🗓️ Primary Completion (Estimated) 31 March 2025

✅ Study Completion (Estimated) 30 April 2025

👥 Enrollment (Estimated) 60

🔬 Study Type INTERVENTIONAL

📊 Phase EARLY_PHASE1

Locations:

📍 Iowa City, Iowa, United States

📋 Eligibility Criteria

Description

Inclusion:
* 18 years or older,
* 12 weeks to 5 years postpartum
* and one of the following:
1. women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy,
2. women who had a normal pregnancy and used LDA during pregnancy,
3. women who had preeclampsia and did not use LDA during pregnancy,
4. 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.

Ages Eligible for Study: 18 Years to 50 Years (ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 7 December 2022
First Submitted that Met QC Criteria 15 December 2022
First Posted 16 December 2022

Study Record Updates