Blood PressurePhase 4NCT05889468
Postpartum ASA and NT-proBNP
A Phase 4 study testing Aspirin 81Mg Ec Tab in people with Blood Pressure, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Aspirin 81Mg Ec Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 21 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.
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
- Being tested
- Aspirin 81Mg Ec Tab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81Mg Ec TabDrug
Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.
PlaceboDrug
Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks postpartum
Secondary outcomes (6)
Number of Participants With Preeclampsia Diagnosis Postpartum
Measured: 6 weeks postpartum
Number of Participants With Eclampsia
Measured: 4-6 weeks postpartum
Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications
Measured: 6 weeks postpartum
Number of Participants Requiring Initiation or Increase in Blood Pressure Medications
Measured: 4-6 weeks postpartum
Number of Participants With Hospital Readmission for Bleeding-related Complications
Measured: 4-6 weeks postpartum
Number of Participants Needing Blood Transfusion(s)
Measured: 4-6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jul 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Arm vs Placebo Arm
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenna Hughes, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889468
- Sponsor's protocol ID
- Pro00112143
- Status last verified
- May 2025
- First submitted
- 25 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Postpartum Aspirin Use and NT-proBNP Levels as a Marker for Maternal Health Outcomes.
- ClinicalTrials.gov ID
- NCT05889468
- Acronym / sponsor ID
- Pro00112143
- Conditions
- Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Treatment Arm vs Placebo Arm
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Aspirin 81Mg Ec TabThe 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. |
| Placebo Group | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- hypersensitivity reaction to aspirin or other salicylates,
- history of gastrointestinal bleeding
- history of gastric or duodenal ulcers
- severe hepatic dysfunction
- bleeding disorders and diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81Mg Ec TabParticipant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission. | Drug | Treatment Group |
| PlaceboParticipant may be provided with a 6-week supply of placebo to discharge from the delivery admission. | Drug | Placebo Group |
Primary outcome
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.
6 secondary outcomes
Number of Participants With Preeclampsia Diagnosis Postpartum
Time frame: 6 weeks postpartum
Number of Participants With Eclampsia
Time frame: 4-6 weeks postpartum
Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications
Time frame: 6 weeks postpartum
Number of Participants Requiring Initiation or Increase in Blood Pressure Medications
Time frame: 4-6 weeks postpartum
Number of Participants With Hospital Readmission for Bleeding-related Complications
Time frame: 4-6 weeks postpartum
Number of Participants Needing Blood Transfusion(s)
Time frame: 4-6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenna Hughes, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin 81Mg Ec Tab in people with Blood Pressure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP Levels at 4-6 Weeks Postpartum (time frame: 4-6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.