Prenatal Aspirin and Postpartum Vascular Function

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAnna Stanhewicz, PhD

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older,

12 weeks to 5 years postpartum

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,

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Acetylcholine

    Drug

    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

  • Endothelin-1

    Drug

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: assessment of microvascular functionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

microvascular endothelial function

cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME

Time frame
at the study visit, an average of 4 hours
2

microvascular endothelin-1-mediated constriction

cutaneous vascular response to exogenous endothelin-1 perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of endothelin-1 alone or co-infused with BQ-788 or BQ-123

Time frame
at the study visit, an average of 4 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Stanhewicz, PhD

Lead sponsor

University of Iowa

Sponsor institution