Postpartum ASA and NT-proBNP

NCT05889468 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00112143
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• NT-proBNP Levels at 4-6 Weeks Postpartum

  The primary outcome for this analysis was NT-proBNP levels collected at the postpartum visit. Patients were reminded of this appointment the day prior to their scheduled follow-up visit. NT-proBNP levels were drawn at the 4-6 week postpartum visit. If patient did not present to their scheduled appointment, attempts were made to contact the patient and reschedule the visit and collect the lab sample for completion of the study.

  4-6 weeks postpartum

Secondary Outcomes (6)

• Number of Participants With Preeclampsia Diagnosis Postpartum

  6 weeks postpartum

• Number of Participants With Eclampsia

  4-6 weeks postpartum

• Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications

  6 weeks postpartum

• Number of Participants Requiring Initiation or Increase in Blood Pressure Medications

  4-6 weeks postpartum

• Number of Participants With Hospital Readmission for Bleeding-related Complications

  4-6 weeks postpartum

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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.

Drug: Aspirin 81Mg Ec Tab

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Aspirin 81Mg Ec Tab DRUG

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

Treatment Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Brenna L. Hughes, MD, MSc
• Organization: Duke University Medical Center

brenna.hughes@duke.edu

919-684-8111

Study Officials

• Brenna Hughes, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 1:1 fashion to aspirin 81 mg vs identical-appearing placebo to be continued for 6 weeks' postpartum. Patients will receive these medications prior to hospital discharge. Both the patient and provider will be blinded to their assigned group. NT-proBNP levels will be drawn at the 4-6-week postpartum visit. NT-proBNP levels will be compared between groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment Arm vs Placebo Arm

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: July 1, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)