Postpartum ASA and NT-proBNP

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05889468

Enrollment

114

Registered

2023-06-05

Start date

2023-07-01

Completion date

2024-05-21

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief 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.

Interventions

DRUGAspirin 81Mg Ec Tab

Participant may be provided with a 6-week supply of 81 mg of aspirin prior to discharge from the delivery admission.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

1:1 fashion to aspirin 81 mg vs identical-appearing placebo to be continued for 6 weeks' postpartum. Patients will receive these medications prior to hospital discharge. Both the patient and provider will be blinded to their assigned group. NT-proBNP levels will be drawn at the 4-6-week postpartum visit. NT-proBNP levels will be compared between groups.

Intervention model description

Treatment Arm vs Placebo Arm

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
NT-proBNP Levels at 4-6 Weeks Postpartum	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

Measure	Time frame
Number of Participants With Eclampsia	4-6 weeks postpartum
Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications	6 weeks postpartum
Number of Participants With Preeclampsia Diagnosis Postpartum	6 weeks postpartum
Number of Participants With Hospital Readmission for Bleeding-related Complications	4-6 weeks postpartum
Number of Participants Needing Blood Transfusion(s)	4-6 weeks postpartum
Number of Participants Requiring Initiation or Increase in Blood Pressure Medications	4-6 weeks postpartum

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	55
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.	55
Total	110

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	9	2
Overall Study	Withdrawal by Subject	2	2

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 55	0 / 55
other Total, other adverse events	2 / 55	5 / 55
serious Total, serious adverse events	5 / 55	6 / 55

Outcome results

Primary

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.

Time frame: 4-6 weeks postpartum