Daily Aspirin Treatment After Preeclampsia

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

About this trial

Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

had preeclampsia in the past 5 years,

18 years or older

Disqualifiers

current daily aspirin use,

skin diseases,

current tobacco or nicotine use (including vaping),

diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    162mg aspirin capsule

  • Placebo

    Drug

    placebo capsule

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: aspirinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

magnitude of microvascular endothelial function

skin blood flow response to acetylcholine delivered via intradermal microdialysis

Time frame
baseline, 12 weeks
2

magnitude of brachial artery endothelial function

brachial artery flow mediated dilation

Time frame
baseline, 12 weeks
3

magnitude of microvascular endothelin-1 mediated constriction

skin blood flow response to endothelin-1 delivered via intradermal microdialysis

Time frame
baseline, 12 weeks

Secondary outcomes

1

magnitude of microvascular nitric oxide-dependent dilation

skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis

Time frame
baseline, 12 weeks

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