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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 : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Kirsten Lawrence Cleary, Columbia University

Tracking Information
First Submitted Date  ICMJE August 27, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date January 21, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
Change in Flow-Mediated Dilation (FMD) [ Time Frame: Up to 6 weeks postpartum ]
This is designed to measure if patients with preeclampsia (with or without severe features), diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 6 weeks after delivery when taking daily LDA in the postpartum period.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Change in mean arterial pressure (MAP) [ Time Frame: Up to 2 weeks postpartum ]
This is designed to measure if patients with preeclampsia (with or without severe features), diagnosed antepartum or intrapartum, will experience a decrease in mean arterial pressure (MAP) within 2 weeks after delivery when taking daily LDA in the postpartum period.
Change History Complete list of historical versions of study NCT03667326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
  • Change in Systolic blood pressure [ Time Frame: Within 2 weeks and up to 6 weeks postpartum ]
    This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 2 weeks and up to 6 weeks after delivery when taking daily LDA in the postpartum period.
  • Change in Diastolic blood pressure [ Time Frame: Within 2 weeks and up to 6 weeks postpartum ]
    This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 2 weeks and up to 6 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) [ Time Frame: Up to 6 weeks postpartum ]
    This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.
  • Magnesium sulfate administration [ Time Frame: Up to 6 weeks postpartum ]
    This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum when taking daily LDA in the postpartum period?
  • Number of subjects with initiation of, increase in or addition of blood pressure medication [ Time Frame: Up to 6 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.
  • Rate of hospital readmissions for postpartum preeclampsia [ Time Frame: Up to 6 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • Change in Systolic blood pressure [ Time Frame: Up to 2 weeks postpartum ]
    This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 2 weeks after delivery when taking daily LDA in the postpartum period.
  • Change in Diastolic blood pressure [ Time Frame: Up to 2 weeks postpartum ]
    This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 2 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) [ Time Frame: Up to 6 weeks postpartum ]
    This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.
  • Magnesium sulfate administration [ Time Frame: Up to 6 weeks postpartum ]
    This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum when taking daily LDA in the postpartum period?
  • Number of subjects with initiation of, increase in or addition of blood pressure medication [ Time Frame: Up to 6 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.
  • Rate of hospital readmissions for postpartum preeclampsia [ Time Frame: Up to 6 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postpartum Low-Dose Aspirin and Preeclampsia
Official Title  ICMJE Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Brief Summary The purpose of this research study is to find out whether women with preeclampsia taking low-dose aspirin (LDA) for 6 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 preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 6 weeks post-delivery.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Preeclampsia Postpartum
Intervention  ICMJE
  • Drug: Aspirin
    Low dose aspirin, 81mg tablets, PO
  • Drug: Placebo oral capsule
    Placebo oral capsule, PO
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Low-Dose Aspirin (LDA) Intervention Group
    Subjects diagnosed with preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 6 weeks postpartum, starting 1-2 days after delivery.
    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo Control Group
    Subjects diagnosed with preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 6 weeks postpartum, starting 1-2 days after delivery.
    Intervention: Drug: Placebo oral capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
100
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Singleton gestation
  • Maternal age >= 18 years
  • 20 0/7 to 40 6/7 weeks gestation
  • Preeclampsia diagnosed prior to delivery

Exclusion Criteria:

  • Multiple gestation
  • Aspirin use postpartum for other medical indication
  • 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
  • Renal or severe hepatic dysfunction
  • Bleeding diathesis
  • Breastfeeding a newborn with low platelets (NAIT)
  • Patients enrolled in the Pravastatin and Chronic Hypertension and Pregnancy (CHAP) studies
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kirsten Cleary, MD 212-305-6293 klc2108@cumc.columbia.edu
Contact: Aleha Aziz, MD, MPH 646-678-0289 aa4065@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667326
Other Study ID Numbers  ICMJE AAAR9439
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kirsten Lawrence Cleary, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kirsten Cleary, MD Assistant Professor of Obstetrics and Gynecology at the Columbia
PRS Account Columbia University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP