Postpartum ASA and NT-proBNP

Blood Pressure Clinical Trial

Official title:

The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05889468
• Other study ID #: Pro00112143
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP levels at 4 weeks postpartum	NT-proBNP levels at 4 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo.	4 weeks postpartum
Primary	NT-proBNP levels at 6 weeks postpartum	NT-proBNP levels at 6 weeks postpartum. Patients continued on 6 weeks of aspirin use postpartum and placebo.	6 weeks postpartum
Secondary	Average Blood Pressures	To compare average blood pressure readings at the 4-6 week postpartum visits.	6 weeks postpartum
Secondary	Rate of preeclampsia diagnosis postpartum		6 weeks postpartum
Secondary	Rate of eclampsia		6 weeks postpartum
Secondary	Hospital readmission rates for blood pressure monitoring or cardiovascular disease work-up indications		6 weeks postpartum
Secondary	Number of subjects requiring initiation or increase in blood pressure medications		6 weeks postpartum
Secondary	hospital readmission rates for bleeding-related complications		6 weeks postpartum
Secondary	Rate of blood transfusions		6 weeks postpartum