Phase 4
N=110
Postpartum ASA and NT-proBNP
Blood Pressure
Bottom Line
View on ClinicalTrials.gov: NCT05889468 ↗Enrolled (actual)
110
Serious AEs
10.0%
Results posted
Jun 2025
Primary outcome: Primary: NT-proBNP Levels at 4-6 Weeks Postpartum — 36.5; 39.5 pg/mL — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aspirin 81Mg Ec Tab (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NT-proBNP Levels at 4-6 Weeks Postpartum |
36.5; 39.5 | 0.49 |
| SECONDARY Number of Participants With Preeclampsia Diagnosis Postpartum |
3; 7 | 0.32 |
| SECONDARY Number of Participants With Eclampsia |
0; 0 | — |
| SECONDARY Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications |
3; 3 | >0.99 |
| SECONDARY Number of Participants Requiring Initiation or Increase in Blood Pressure Medications |
3; 4 | >0.99 |
| SECONDARY Number of Participants With Hospital Readmission for Bleeding-related Complications |
0; 0 | — |
| SECONDARY Number of Participants Needing Blood Transfusion(s) |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05889468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.