Trial Outcomes & Findings for Postpartum ASA and NT-proBNP (NCT NCT05889468)

NCT ID: NCT05889468

Last Updated: 2025-06-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: 4-6 weeks postpartum
• Results posted on: 2025-06-04

Participant Flow

Patients meeting inclusion criteria were approached for enrollment during routine prenatal visits at Duke Perinatal Clinic and on Duke Birthing Center's Labor and Delivery Unit.

Four participants were consented but did not start the study because they did not deliver within the Duke Hospital System or required Intensive Care Unit (ICU) admission during their delivery hospitalization.

Participant milestones

Measure	Treatment Group 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.	Placebo Group 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.
Overall Study STARTED	55	55
Overall Study COMPLETED	44	51
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Measure	Treatment Group 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.	Placebo Group 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.
Overall Study Lost to Follow-up	9	2
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Postpartum ASA and NT-proBNP

Baseline characteristics by cohort

Measure	Treatment Group n=55 Participants 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.	Placebo Group n=55 Participants 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.	Total n=110 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 5.4 • n=5 Participants	32.2 years STANDARD_DEVIATION 5.9 • n=7 Participants	32.0 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	51 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks postpartum

Population: Participants who completed the study.

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.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
NT-proBNP Levels at 4-6 Weeks Postpartum	36.5 pg/mL Interval 36.0 to 61.0	39.5 pg/mL Interval 36.0 to 74.0

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants With Preeclampsia Diagnosis Postpartum	3 Participants	7 Participants

SECONDARY outcome

Timeframe: 4-6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants With Eclampsia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 4-6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants Requiring Initiation or Increase in Blood Pressure Medications	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 4-6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants With Hospital Readmission for Bleeding-related Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4-6 weeks postpartum

Population: Participants who completed the study.

Outcome measures

Measure	Treatment Group n=44 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants Needing Blood Transfusion(s)	0 Participants	0 Participants

Adverse Events

Treatment Group

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Group

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=55 participants at risk 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. 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 Group n=55 participants at risk 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. Placebo: Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.
Cardiac disorders Unexpected hospitalization (preeclampsia or cardiovascular-related)	5.5% 3/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.	5.5% 3/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.
Blood and lymphatic system disorders Unexpected hospitalization (bleeding related)	0.00% 0/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.	1.8% 1/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.
Infections and infestations Unexpected hospitalization (infection or wound complication)	3.6% 2/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.	3.6% 2/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.

Other adverse events

Measure	Treatment Group n=55 participants at risk 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. 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 Group n=55 participants at risk 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. Placebo: Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission.
Gastrointestinal disorders Gastrointestinal symptoms	0.00% 0/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.	1.8% 1/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.
Pregnancy, puerperium and perinatal conditions Postpartum triage visit	3.6% 2/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.	7.3% 4/55 • 4-6 weeks postpartum Prespecified minor adverse events included GI symptoms or minor bleeding events. Major bleeding, defined by ISTH as 1) fatal bleeding, 2) symptomatic bleeding in a critical organ, or 3) bleeding causing a fall in hemoglobin level of 20 g/l or more or leading to transfusion of 2 or more units of whole blood or red cells, as well as anaphylactic reactions, unexpected hospitalizations, and death were reported as major adverse events.

Additional Information

Brenna L. Hughes, MD, MSc

Duke University Medical Center

Phone: 919-684-8111

Email: brenna.hughes@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place