search
Back to results

Postpartum Low-Dose Aspirin and Preeclampsia

Primary Purpose

Preeclampsia Postpartum

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin tablet
Placebo oral capsule
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia Postpartum focused on measuring Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Low-Dose Aspirin (LDA) Intervention Group

Placebo Control Group

Healthy Controls Group

Arm Description

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.

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.

Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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?
Number of subjects with initiation of, increase in or addition of blood pressure medication
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.
Rate of hospital readmissions for postpartum preeclampsia
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.

Full Information

First Posted
August 27, 2018
Last Updated
December 23, 2022
Sponsor
Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT03667326
Brief Title
Postpartum Low-Dose Aspirin and Preeclampsia
Official Title
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Postpartum
Keywords
Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Preeclampsia patients will be recruited and randomized to receive either Aspirin or Placebo (n = 90). Additionally, there will be healthy patients (n = 10) recruited to collect the same set of data for comparison with no intervention.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Dose Aspirin (LDA) Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Healthy Controls Group
Arm Type
No Intervention
Arm Description
Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.
Intervention Type
Drug
Intervention Name(s)
Aspirin tablet
Other Intervention Name(s)
Aspirin
Intervention Description
Low dose aspirin, 81mg tablets, PO
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule, PO
Primary Outcome Measure Information:
Title
Change in Flow-Mediated Dilation (FMD)
Description
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 Outcome Measure Information:
Title
Change in Systolic blood pressure
Description
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
Title
Change in Diastolic blood pressure
Description
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
Title
Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities)
Description
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
Title
Magnesium sulfate re-administration
Description
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
Title
Number of subjects with initiation of, increase in or addition of blood pressure medication
Description
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.
Time Frame
Up to 3 weeks postpartum
Title
Rate of hospital readmissions for postpartum preeclampsia
Description
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.
Time Frame
Up to 3 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleha Aziz, MD, MPH
Phone
646-678-0289
Email
aa4065@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Bello, MD, MPH
Phone
212-305-1436
Email
nb338@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleha Aziz, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleha Aziz, MD, MPH
Phone
646-678-0289
Email
aa4065@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Natalie Bello, MD, MPH
Phone
212-305-1436
Email
nb338@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Natalie Bello, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
background
PubMed Identifier
28684123
Citation
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.
Results Reference
background

Learn more about this trial

Postpartum Low-Dose Aspirin and Preeclampsia

We'll reach out to this number within 24 hrs