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Completed

NCT Number: NCT05889468

Postpartum ASA and NT-proBNP

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.

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Key information

Conditions

Blood Pressure

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. NT-proBNP Levels at 4-6 Weeks Postpartum

    Time frame: 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.

Secondary outcomes

  1. Number of Participants With Preeclampsia Diagnosis Postpartum

    Time frame: 6 weeks postpartum

  2. Number of Participants With Eclampsia

    Time frame: 4-6 weeks postpartum

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

    Time frame: 6 weeks postpartum

  4. Number of Participants Requiring Initiation or Increase in Blood Pressure Medications

    Time frame: 4-6 weeks postpartum

  5. Number of Participants With Hospital Readmission for Bleeding-related Complications

    Time frame: 4-6 weeks postpartum

  6. Number of Participants Needing Blood Transfusion(s)

    Time frame: 4-6 weeks postpartum

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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