Postpartum Low-Dose Aspirin and Preeclampsia

December 23, 2022 updated by: Columbia University

Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natalie Bello, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Aspirin
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:
  • Placebo
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aleha Aziz, MD, MPH, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia Postpartum

Clinical Trials on Placebo oral capsule

Subscribe