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Prenatal Aspirin and Postpartum Vascular Function

Protective Mechanisms of Prenatal Aspirin Therapy on Maternal Vascular Dysfunction Following Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how low-dose aspirin taken during pregnancy may help blood vessels work after birth. It is for women who had a normal pregnancy or preeclampsia, a pregnancy disorder involving high blood pressure. Researchers will test small blood vessels in the skin and collect blood samples.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Gave birth 12 weeks to 5 years ago.
  • Had a normal pregnancy or preeclampsia, with or without low-dose aspirin use during pregnancy.

Who can't join

  • Currently take aspirin every day or use tobacco.
  • Have a skin disease.
  • Have a known or suspected liver disease or a disease that affects how the body processes food and energy, including long-term kidney disease with a kidney filtering rate below 60.
  • Currently take medicine to lower cholesterol or blood pressure.
  • Had high blood pressure before pregnancy or diabetes during pregnancy.
  • Are currently pregnant.
  • Have a body mass index (BMI), a measure of weight compared with height, below 18.5.
  • Are allergic to study drugs or materials used in the study, such as latex.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

IA