Postpartum ASA and NT-proBNP

NCT ID: NCT05889468

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-05-21

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

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.

Group Type: ACTIVE_COMPARATOR

Aspirin 81Mg Ec Tab

Intervention Type: DRUG

Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.

Interventions

Aspirin 81Mg Ec Tab

Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.

Intervention Type: DRUG

Placebo

Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenna Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00112143

Identifier Type: -

Identifier Source: org_study_id