Postpartum ASA and NT-proBNP

Duke University

Status and phase: Completed; Phase 4

Conditions: Blood Pressure

Treatments: Drug: Placebo; Drug: Aspirin 81Mg Ec Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05889468

Pro00112143

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin 81Mg Ec Tab

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo