Postpartum ASA and NT-proBNP

Phase 4

Completed

• Conditions: Blood Pressure
• Interventions: Drug: Aspirin 81Mg Ec Tab; Drug: Placebo

• Registration Number: NCT05889468
• Lead Sponsor: Duke University

Brief Summary

This study is a double-blinded randomized-controlled trial in which patients will be randomized to 81 mg of aspirin or placebo to be continued for 6 weeks' postpartum. The purpose of this study is to compare NT-proBNP levels at the 4-6 week postpartum visit between groups. There is currently no data on the maternal health effects associated with continuation of low-dose aspirin in the postpartum period. This study aims to fill a gap in the knowledge regarding the utility of low-dose aspirin following delivery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2023-07-01
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• 18 years of age and older
• English-speaking
• postpartum
• have met USPSTF recommendations for low-dose aspirin use during pregnancy: >1 high risk factor (history of preeclampsia in prior pregnancy, multifetal gestational, chronic hypertension, preexisting diabetes, renal disease, autoimmune disease) or >2 moderate risk factors (nulliparity, obesity, family history of preeclampsia, sociodemographic characteristics, age 35 years or older, or personal history factors) and reported at least 50% compliance with aspirin during pregnancy.

Exclusion Criteria

• hypersensitivity reaction to aspirin or other salicylates,
• history of gastrointestinal bleeding
• history of gastric or duodenal ulcers
• severe hepatic dysfunction
• bleeding disorders and diathesis
• known cardiac dysfunction with reduced ejection fraction, or are taking or prescribed ACE inhibitors.
• Patients who required ICU level care during their pregnancy will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Aspirin 81Mg Ec Tab	The treatment group will be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal.
Placebo Group	Placebo	The control group will receive a 6-week supply of placebo medication from the Investigational Pharmacy prior to discharge. The placebo will be identically appearing to the 81 mg aspirin. Patients will be scheduled for a 4-6 week postpartum clinic appointment, which is standard for these patients outside of this proposal.

Primary Outcome Measures

Name	Time	Method
NT-proBNP levels at 4 weeks postpartum	4 weeks postpartum	NT-proBNP levels at 4 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo.
NT-proBNP levels at 6 weeks postpartum	6 weeks postpartum	NT-proBNP levels at 6 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo.

Secondary Outcome Measures

Name	Time	Method
Rate of blood transfusions	6 weeks postpartum
Average Blood Pressures	6 weeks postpartum	To compare average blood pressure readings at the 4-6 week postpartum visits.
Rate of preeclampsia diagnosis postpartum	6 weeks postpartum
Hospital readmission rates for blood pressure monitoring or cardiovascular disease work-up indications	6 weeks postpartum
hospital readmission rates for bleeding-related complications	6 weeks postpartum
Rate of eclampsia	6 weeks postpartum
Number of subjects requiring initiation or increase in blood pressure medications	6 weeks postpartum

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States