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Postpartum Low-Dose Aspirin and Preeclampsia

ConditionPreeclampsia Postpartum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Singleton or Multiple gestation

Maternal age >= 18 years

20 0/7 weeks gestation or greater

Severe Preeclampsia diagnosed prior to delivery

Disqualifiers

Aspirin use postpartum for other medical indication

Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)

Aspirin use within 7 days of planned initial FMD testing postpartum

Hypersensitivity or allergy to Aspirin or other salicylates

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin tablet

    Drug

    Low dose aspirin, 81mg tablets, PO

  • Placebo oral capsule

    Drug

    Placebo oral capsule, PO

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Low-Dose Aspirin (LDA) Intervention GroupActive comparator 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Group C: Healthy Controls GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Flow-Mediated Dilation (FMD)

This is designed to measure if patients with preeclampsia with severe features diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 3 weeks after delivery when taking daily LDA in the postpartum period.

Time frame
Up to 3 weeks postpartum

Secondary outcomes

1

Change in Systolic blood pressure

This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.

Time frame
Within 3 weeks postpartum
2

Change in Diastolic blood pressure

This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.

Time frame
Within 3 weeks postpartum
3

Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities)

This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.

Time frame
Up to 3 weeks postpartum
4

Magnesium sulfate re-administration

This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum again when taking daily LDA in the postpartum period?

Time frame
Up to 3 weeks postpartum

Other outcomes

Sponsors and contacts

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

Columbia University

Lead sponsor

Source ClinicalTrials.gov
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