RecruitingEarly Phase 1NCT05653973

Prenatal Aspirin and Postpartum Vascular Function

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


Sponsor

Anna Stanhewicz, PhD

Enrollment

60 participants

Start Date

Jan 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

  • years or older,
  • 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 Criteria12

  • 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.

Interventions

DRUGAcetylcholine

acetylcholine, and acetylcholine + L-NAME (Nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelium- and nitric oxide-dependent dilation

DRUGEndothelin-1

endothelin-1, endothelin-1 + BQ-788 (endothelin receptor type B-inhibitor), and endothelin-1 + BQ-123 (endothelin receptor type A-inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelin-mediated constriction and the role of the receptor subtypes in this response.


Locations(1)

University of Iowa

Iowa City, Iowa, United States

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NCT05653973


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