Postpartum Low-Dose Aspirin and Preeclampsia

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03667326
Phase
PHASE2
Status
Recruiting
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Conditions

  • Preeclampsia Postpartum

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aspirin tablet — DRUG
    Low dose aspirin, 81mg tablets, PO
  • Placebo oral capsule — DRUG
    Placebo oral capsule, PO

Study Details

The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.

Key Dates

Start date
Jul 22, 2019
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Low-Dose Aspirin (LDA) Intervention Group
    Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery.
  • Placebo Comparator: Placebo Control Group
    Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery.
  • No Intervention: Healthy Controls Group
    Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Primary Outcome Measure

Change in Flow-Mediated Dilation (FMD) [ Time Frame: Up to 3 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Aleha Aziz, MD, MPH
[email protected]
646-678-0289
Aleha Aziz, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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