Postpartum Low-Dose Aspirin and Preeclampsia

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

Sponsors

Lead Sponsor: Columbia University

Source 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.

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.

Overall Status Recruiting
Start Date July 22, 2019
Completion Date June 2021
Primary Completion Date December 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Flow-Mediated Dilation (FMD) Up to 3 weeks postpartum
Secondary Outcome
Measure Time Frame
Change in Systolic blood pressure Within 3 weeks postpartum
Change in Diastolic blood pressure Within 3 weeks postpartum
Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities) Up to 3 weeks postpartum
Magnesium sulfate re-administration Up to 3 weeks postpartum
Number of subjects with initiation of, increase in or addition of blood pressure medication Up to 3 weeks postpartum
Rate of hospital readmissions for postpartum preeclampsia Up to 3 weeks postpartum
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Aspirin

Description: Low dose aspirin, 81mg tablets, PO

Arm Group Label: Low-Dose Aspirin (LDA) Intervention Group

Intervention Type: Drug

Intervention Name: Placebo oral capsule

Description: Placebo oral capsule, PO

Arm Group Label: Placebo Control Group

Other Name: Placebo

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)

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Natalie Bello, MD, MPH Principal Investigator Assistant Professor of Medicine at CUIMC
Overall Contact

Last Name: Natalie Bello, MD, MPH

Phone: 212-305-1436

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Columbia University Irving Medical Center Aleha Aziz, MD, MPH 646-678-0289 [email protected] Natalie Bello, MD, MPH Principal Investigator
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Columbia University

Investigator Full Name: Natalie Bello

Investigator Title: Assistant Professor of Medicine at CUIMC

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Low-Dose Aspirin (LDA) Intervention Group

Type: Active Comparator

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.

Label: Placebo Control Group

Type: Placebo Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov