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RecruitingNCT06168461Updated Dec 15, 2025

Daily Aspirin Treatment After Preeclampsia

An Early Phase 1 interventional study of Aspirin and Placebo in Preeclampsia, sponsored by Anna Stanhewicz, PhD. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Anna Stanhewicz, PhD · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Preeclampsia

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Keywords

  • preeclampsia
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 40 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Anna Stanhewicz, PhD is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • had preeclampsia in the past 5 years,
  • 18 years or older

Exclusion criteria

Exclusion criteria:

  • 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,
  • statin or other cholesterol-lowering medication,
  • current antihypertensive medication,
  • history of hypertension prior to pregnancy,
  • history of gestational diabetes,
  • currently pregnancy,
  • body mass index \<18.5 kg/m2,
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergies to study drugs,
  • bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).
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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    placebo pill taken once daily at bedtime for 12 weeks

    Drug: Placebo

  • Experimental
    aspirin

    162mg aspirin taken once daily at bedtime for 12 weeks

    Drug: Aspirin

Interventions

  • DrugAspirin

    162mg aspirin capsule

  • DrugPlacebo

    placebo capsule

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06168461
Lead sponsor
Anna Stanhewicz, PhD
Responsible party
Anna Stanhewicz, PhD (Assistant Professor, University of Iowa) — Sponsor-investigator
First posted
Dec 13, 2023
Start date
Nov 1, 2023
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Dec 15, 2025

Study contacts

Anna Reid-Stanhewicz, PHD
Contact
anna-stanhewicz@uiowa.edu
319-467-1732

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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