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Postpartum Low-Dose Aspirin and Preeclampsia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2025 to Jun 2026 Completion date: Dec 2025 to Dec 2026 · Site contact updatedv10 Show 2 more changesShow less
    • Completion date: Dec 2025 to Dec 2026
    • Site contact updated
  2. Primary completion date: Jun 2023 to Jun 2025 Completion date: Dec 2023 to Dec 2025v9 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2025
  3. Primary completion date: Dec 2021 to Jun 2023 Enrollment target: 90 to 100 · Completion date: Jun 2022 to Dec 2023 · Interventions: Aspirin (Drug), Placebo oral capsule (Drug) to Aspirin tablet (Drug), Placebo oral capsule (Drug) · 3 morev8 Show 6 more changesShow less
    • Enrollment target: 90 to 100
    • Completion date: Jun 2022 to Dec 2023
    • Interventions: Aspirin (Drug), Placebo oral capsule (Drug) to Aspirin tablet (Drug), Placebo oral capsule (Drug)
    • Eligibility criteria expanded, about 28 words
    • Study description expanded, about 33 words
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2020 to Dec 2021 Completion date: Jun 2021 to Jun 2022 · Site contact updatedv7 Show 2 more changesShow less
    • Completion date: Jun 2021 to Jun 2022
    • Site contact updated
  5. Primary completion date: Apr 2020 to Dec 2020 Completion date: Jun 2020 to Jun 2021v6 Show 1 more changeShow less
    • Completion date: Jun 2020 to Jun 2021
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jan 7, 2019 to Jul 22, 2019 Primary completion date: Dec 2019 to Apr 2020 · Completion date: Apr 2020 to Jun 2020 · Eligibility criteria expanded, about 7 words · 1 morev5 Show 4 more changesShow less
    • Primary completion date: Dec 2019 to Apr 2020
    • Completion date: Apr 2020 to Jun 2020
    • Eligibility criteria expanded, about 7 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 160 to 90 Eligibility criteria expanded, about 14 words · Secondary endpoints revised (6)v4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2019 to Jan 7, 2019 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2019 to Jan 7, 2019
    • Site details revised
  4. Enrollment target: 100 to 160 Start date: Sep 2018 to Jan 2019 · Primary endpoint revised · Primary completion date: Jun 2019 to Dec 2019 · 5 morev2 Show 8 more changesShow less
    • Start date: Sep 2018 to Jan 2019
    • Primary endpoint revised
    • Primary completion date: Jun 2019 to Dec 2019
    • Completion date: Sep 2019 to Apr 2020
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 67 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03667326
Lead Sponsor Columbia University
Conditions Preeclampsia Postpartum
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov