Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Preeclampsia Diagnosis Postpartum | 6 weeks postpartum | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brenna Hughes, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the study. | Posted | Median | Inter-Quartile Range | pg/mL | 4-6 weeks postpartum |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected hospitalization (preeclampsia or cardiovascular-related) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenna L. Hughes, MD, MSc | Duke University Medical Center | 919-684-8111 | brenna.hughes@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2024 | May 7, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Treatment Arm vs Placebo Arm
Not provided
Not provided
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.
| Placebo | Drug | Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission. |
|
| 6 weeks postpartum |
| Number of Participants Requiring Initiation or Increase in Blood Pressure Medications | 4-6 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Number of Participants With Preeclampsia Diagnosis Postpartum | Participants who completed the study. | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
|
|
|
| Secondary | Number of Participants With Eclampsia | Participants who completed the study. | Posted | Count of Participants | Participants | 4-6 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Hospital Readmission for Blood Pressure Monitoring or Cardiovascular Disease Work-up Indications | Participants who completed the study. | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
|
|
|
| Secondary | Number of Participants Requiring Initiation or Increase in Blood Pressure Medications | Participants who completed the study. | Posted | Count of Participants | Participants | 4-6 weeks postpartum |
|
|
|
|
| Secondary | Number of Participants With Hospital Readmission for Bleeding-related Complications | Participants who completed the study. | Posted | Count of Participants | Participants | 4-6 weeks postpartum |
|
|
|
| Secondary | Number of Participants Needing Blood Transfusion(s) | Participants who completed the study. | Posted | Count of Participants | Participants | 4-6 weeks postpartum |
|
|
|
| 0 |
| 55 |
| 5 |
| 55 |
| 2 |
| 55 |
| EG001 | 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. Placebo: Participant may be provided with a 6-week supply of placebo to discharge from the delivery admission. | 0 | 55 | 6 | 55 | 5 | 55 |
| Unexpected hospitalization (bleeding related) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Unexpected hospitalization (infection or wound complication) | Infections and infestations | Systematic Assessment |
|
| Postpartum triage visit | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |