- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667326
Postpartum Low-Dose Aspirin and Preeclampsia
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Study Overview
Status
Conditions
Intervention / Treatment
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, i.e., 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.
Investigator will also explore a small sub-study to gather information regarding baseline FMD and biomarker values for healthy control postpartum patients, unaffected by preeclampsia and not on LDA during pregnancy or postpartum.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Aleha Aziz, MD, MPH
- Phone Number: 646-678-0289
- Email: aa4065@cumc.columbia.edu
Study Contact Backup
- Name: Natalie Bello, MD, MPH
- Phone Number: 212-305-1436
- Email: nb338@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Contact:
- Aleha Aziz, MD, MPH
- Phone Number: 646-678-0289
- Email: aa4065@cumc.columbia.edu
-
Contact:
- Natalie Bello, MD, MPH
- Phone Number: 212-305-1436
- Email: nb338@cumc.columbia.edu
-
Principal Investigator:
- Natalie Bello, MD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 7 days of planned initial FMD testing postpartum
- Hypersensitivity or allergy to Aspirin or other salicylates
- Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
- Nasal polyps
- Gastric or Duodenal ulcers, history of GI bleeding
- Severe hepatic dysfunction
- Bleeding disorders and diathesis
- Breastfeeding a newborn with low platelets (NAIT)
For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion for healthy controls group).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Low dose aspirin, 81mg tablets, PO
Other Names:
|
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.
|
Placebo oral capsule, PO
Other Names:
|
No Intervention: Healthy Controls Group
Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 3 weeks postpartum
|
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.
|
Within 3 weeks postpartum
|
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.
|
Up to 3 weeks postpartum
|
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?
|
Up to 3 weeks postpartum
|
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.
|
Up to 3 weeks postpartum
|
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.
|
Up to 3 weeks postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aleha Aziz, MD, MPH, Columbia University
Publications and helpful links
General 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
- Costa AC, Reina-Couto M, Albino-Teixeira A, Sousa T. Aspirin and blood pressure: Effects when used alone or in combination with antihypertensive drugs. Rev Port Cardiol. 2017 Jul-Aug;36(7-8):551-567. doi: 10.1016/j.repc.2017.05.008. Epub 2017 Jul 3. English, Portuguese.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Pre-Eclampsia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- AAAR9439
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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