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Postpartum Low-Dose Aspirin and Preeclampsia

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ClinicalTrials.gov Identifier: NCT03667326
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Kirsten Lawrence Cleary, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preeclampsia Postpartum Drug: Aspirin Drug: Placebo oral capsule Phase 2

Detailed Description:

Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with the condition are at increased risk for complications during pregnancy, including seizures - eclampsia. Babies are at risk of being born premature because the only cure for preeclampsia is delivery. Women who have had preeclampsia are also at increased risk of cardiovascular and kidney disease later in life, including heart attack, stroke and high blood pressure.Studies show that women at high risk for preeclampsia, ie. have had preeclampsia in a prior pregnancy, are carrying more than one fetus, have a history of high blood pressure, kidney disease or both, have certain medical problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.

Due to the limited data available on the topic of LDA in preeclamptic patients in the postpartum period, particularly as applicable to the American population, the investigator intends to start with a small pilot study involving the collection of information on 10 women not exposed to study intervention. This will allow for confirmation of the sample size based on the baseline FMD measurements 2 days after delivery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Aspirin

Arm Intervention/treatment
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.
Drug: Aspirin
Low dose aspirin, 81mg tablets, PO

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.
Drug: Placebo oral capsule
Placebo oral capsule, PO
Other Name: Placebo




Primary Outcome Measures :
  1. Change in Flow-Mediated Dilation (FMD) [ Time Frame: Up to 3 weeks postpartum ]
    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.


Secondary Outcome Measures :
  1. Change in Systolic blood pressure [ Time Frame: Within 3 weeks postpartum ]
    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.

  2. Change in Diastolic blood pressure [ Time Frame: Within 3 weeks postpartum ]
    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.

  3. Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities) [ Time Frame: Up to 3 weeks postpartum ]
    This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.

  4. Magnesium sulfate re-administration [ Time Frame: Up to 3 weeks postpartum ]
    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?

  5. Number of subjects with initiation of, increase in or addition of blood pressure medication [ Time Frame: Up to 3 weeks postpartum ]
    This is to measure if patients will experience a decreased rate in initiation of/ increase in/ addition of blood pressure medication postpartum when taking daily LDA in the postpartum period.

  6. Rate of hospital readmissions for postpartum preeclampsia [ Time Frame: Up to 3 weeks postpartum ]
    This is to measure if patients will experience a decreased rate of hospital readmissions for postpartum preeclampsia when taking daily LDA in the postpartum period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton or Multiple gestation
  • Maternal age >= 18 years
  • 20 0/7 weeks gestation or greater
  • Severe Preeclampsia diagnosed prior to delivery

Exclusion Criteria:

  • 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 10 days of planned initial FMD testing postpartum
  • Hypersensitivity or allergy to Aspirin or other salicylates
  • Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Nasal polyps
  • Gastric or Duodenal ulcers, history of GI bleeding
  • Severe hepatic dysfunction
  • Bleeding disorders and diathesis
  • Breastfeeding a newborn with low platelets (NAIT)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667326


Contacts
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Contact: Kirsten Cleary, MD 212-305-6293 klc2108@cumc.columbia.edu
Contact: Aleha Aziz, MD, MPH 646-678-0289 aa4065@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Aleha Aziz, MD    646-678-0289    aa4065@cumc.columbia.edu   
Principal Investigator: Kirsten Cleary, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Kirsten Cleary, MD Assistant Professor of Obstetrics and Gynecology at the Columbia

Publications:
The American College of Obstetricians and Gynecologists. Practice Advisory on Low-Dose Aspirin and Prevention of Preeclampsia: Updated Recommendations [Internet]. 2016. Available from: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations

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Responsible Party: Kirsten Lawrence Cleary, Assistant Professor of Obstetrics and Gynecology at the Columbia, Columbia University
ClinicalTrials.gov Identifier: NCT03667326     History of Changes
Other Study ID Numbers: AAAR9439
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kirsten Lawrence Cleary, Columbia University:
Aspirin
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics