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Nonsteroidal Anti-inflammatory Drug
Low-Dose Aspirin for Postpartum Health
Phase 4
Waitlist Available
Led By Brenna Hughes, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks postpartum
Awards & highlights
Study Summary
This trial will investigate how low-dose aspirin affects maternal health after giving birth. It will compare levels of NT-proBNP between those taking aspirin and those taking a placebo.
Who is the study for?
This trial is for English-speaking postpartum individuals who followed USPSTF recommendations for low-dose aspirin during pregnancy due to high or moderate risk factors. Participants must be 18 or older and have taken aspirin regularly during pregnancy. Those with a history of ulcers, severe liver issues, bleeding disorders, certain heart problems, ICU care during pregnancy, or an allergy to aspirin are not eligible.Check my eligibility
What is being tested?
The study tests if continuing low-dose aspirin (81 mg) after childbirth affects NT-proBNP levels at the postpartum visit compared to a placebo. It's double-blinded meaning neither participants nor researchers know who gets real medicine versus placebo until the end of the trial.See study design
What are the potential side effects?
Potential side effects from taking low-dose aspirin may include stomach irritation or increased risk of bleeding. However, since this study involves patients already taking low-dose aspirin during pregnancy without major issues reported, serious side effects might be less likely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
NT-proBNP levels at 4 weeks postpartum
NT-proBNP levels at 6 weeks postpartum
Secondary outcome measures
Average Blood Pressures
Hospital readmission rates for blood pressure monitoring or cardiovascular disease work-up indications
Number of subjects requiring initiation or increase in blood pressure medications
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
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.
Group II: Placebo GroupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,372 Total Patients Enrolled
Brenna Hughes, MDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
411 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had bleeding in my stomach or intestines.I have had stomach or duodenal ulcers in the past.I have severe liver problems.I have a bleeding disorder.I have heart issues with reduced pumping ability or I am on ACE inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Placebo Group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there particular individuals who would be more beneficial to include in this research project?
"In order to be deemed eligible, patients must have high blood pressure and fall between 18 and 60 years of age. This clinical trial is searching for 90 participants in total."
Answered by AI
Are enrollment opportunities for this experiment still accessible?
"According to data posted on clinicaltrials.gov, this medical study is no longer recruiting patients as it was initially published June 30th 2023 and last amended May 25th 2023. Nevertheless, there are 102 other studies that still have open enrolment periods right now."
Answered by AI
Has Treatment Group obtained its regulatory clearance from the FDA?
"As this is a Phase 4 trial, and thus approved by the relevant authorities, Treatment Group was calculated to be a 3 on Power's safety scale."
Answered by AI
Does the eligibility criteria for this trial include persons who are sixty or older?
"This medical study seeks to include individuals aged 18 or more and under 60."
Answered by AI
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