Low-Dose Aspirin for Preeclampsia

(TAP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Alisse Hauspurg, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Alisse Hauspurg

Disqualifiers: Fetal anomaly, Multiple gestation, Hypertension, Diabetes, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have an allergy or contraindication to low-dose aspirin, you cannot participate.

What data supports the effectiveness of the drug low-dose aspirin for preeclampsia?

Research shows that low-dose aspirin can reduce the risk of preeclampsia by about 25% in women who are at high risk, especially if started early in pregnancy. It is considered safe for both the mother and baby. ^{1 2 3 4 5}

Is low-dose aspirin safe for use in pregnant women?

Low-dose aspirin appears to be safe for both the mother and the baby during pregnancy, with studies showing no significant risks to the fetus or newborn. ^{1 2 3 5 6}

How does low-dose aspirin differ from other drugs for preeclampsia?

Low-dose aspirin is unique because it is used as a preventive measure for preeclampsia, especially in women at high risk, and is considered safe during pregnancy. It is recommended to start between 12 and 28 weeks of gestation and is associated with a reduced risk of developing preeclampsia, although its effectiveness can vary based on individual risk factors. ^{1 2 6 7 8}

Research Team

Alisse Hauspurg, MD

Principal Investigator

UPMC Magee Women's Hospital

Eligibility Criteria

This trial is for postpartum individuals over 18 who were diagnosed with preeclampsia. It's not open to those with pre-pregnancy hypertension or diabetes, allergies to aspirin, multiple gestations, fetal anomalies, or anyone who used aspirin during pregnancy.

Inclusion Criteria

I am 18 or older and have recently given birth.

Preeclampsia diagnosis

Exclusion Criteria

I had high blood pressure before getting pregnant.

Multiple gestation

Pre-pregnancy diabetes

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-dose aspirin or placebo daily for six months postpartum

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

Treatment Details

Interventions

• Low-dose aspirin (Antiplatelet Agent)

Trial Overview The TAP Trial is testing if low-dose aspirin can help improve blood vessel function and lower blood pressure after preeclampsia. Participants will be randomly given either aspirin or a placebo and monitored through visits involving BP checks and other tests.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects

Group II: Placebo Group Placebo Group 1 Intervention

Similar appearing placebo pill daily for 6 months will be given to subjects.

Low-dose aspirin is already approved in Canada for the following indications:

Approved in Canada as Aspirin for:

• Preeclampsia prophylaxis
• Cardiovascular disease prevention
• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Alisse Hauspurg

Lead Sponsor

Trials

3

Recruited

230+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

Low-dose aspirin can reduce the incidence of pre-eclampsia by about 25%, particularly in high-risk patients, and should ideally be started between 10-14 weeks of pregnancy for maximum effectiveness.

The use of low-dose aspirin is considered safe for both the fetus and neonate, with minimal risk of complications such as abruptio placentae, but further research is needed to optimize treatment strategies and explore combinations with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacological prevention of pre-eclampsia. Dekker, GA.[2019]

Low-dose aspirin has been shown to effectively reduce the risk of preeclampsia and fetal growth restriction in at-risk pregnant populations, but its benefits in low-risk groups remain unclear.

There is ongoing debate among medical organizations regarding the guidelines for aspirin use in pregnancy, with some recommending it only for at-risk women while others suggest it may be more effective and cost-efficient to prescribe it universally from the first trimester.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should we recommend universal aspirin for all pregnant women? Mone, F., Mulcahy, C., McParland, P., et al.[2022]

A systematic review of 8 randomized controlled trials involving 861 patients found that low-dose aspirin combined with low-molecular-weight heparin (LMWH) significantly improved blood pressure and reduced proteinuria in women with preeclampsia, indicating its efficacy in managing this condition.

The combination treatment did not increase adverse perinatal outcomes and showed no significant difference in adverse reactions among pregnant women, suggesting it is a safe option for treating preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of low-dose aspirin combined with low-molecular-weight heparin in treatment of preeclampsia: a meta-analysis and systematic review. Wu, C., Li, L., Zhang, J., et al.[2022]

Low-dose aspirin has been shown to be beneficial in preventing pre-eclampsia in high-risk pregnant women, based on results from four large clinical trials involving over 13,000 participants.

The use of low-dose aspirin is considered safe for mothers and their babies, although its effect on preventing fetal growth retardation is minimal and no significant therapeutic benefits were found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin therapy in obstetrics. Wallenburg, HC.[2019]

A review of 9 studies involving nearly 13,000 pregnant women found that low-dose aspirin treatment significantly reduced the incidence of preeclampsia in 5 smaller studies, but not in 4 larger studies with over 12,000 participants.

The lack of standardized dosing, treatment duration, and risk assessment for both mother and child complicates the evaluation of low-dose aspirin's effectiveness in preventing preeclampsia, making it unclear under what conditions it may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

-Is prevention of pre-eclampsia with low dosage aspirin possible? Critical assessment of available studies-. Lippert, TH., Mück, AO.[2013]

In a study of 716 pregnancies involving women with pregestational diabetes, low-dose aspirin prophylaxis was associated with a higher incidence of preeclampsia, occurring in 20% of those taking aspirin compared to 9% in those who did not (P < 0.001).

Additionally, women with type one diabetes of short duration who used aspirin had an increased risk of having large for gestational age (LGA) infants, with an adjusted odds ratio of 2.21, indicating a significant concern for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between aspirin prophylaxis and fetal growth and preeclampsia in women with pregestational diabetes. Shrestha Khatri, N., White, SW., Graham, DF.[2022]

Daily low-dose aspirin (81 mg) is recommended for pregnant women at high risk of preeclampsia, particularly those with a history of early-onset preeclampsia or multiple prior cases, and should be started between 12 and 28 weeks of gestation for optimal effectiveness.

The use of low-dose aspirin during pregnancy is considered safe, with a low risk of serious complications for both the mother and fetus, and is supported by guidelines from major health organizations for preventing preeclampsia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. [2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The pharmacological prevention of pre-eclampsia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of low-dose aspirin for the prevention of preeclampsia in women at high risk in China. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Should we recommend universal aspirin for all pregnant women? [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of low-dose aspirin combined with low-molecular-weight heparin in treatment of preeclampsia: a meta-analysis and systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Low-dose aspirin therapy in obstetrics. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

-Is prevention of pre-eclampsia with low dosage aspirin possible? Critical assessment of available studies-. [2013]

7. Australia pubmed.ncbi.nlm.nih.gov

Associations between aspirin prophylaxis and fetal growth and preeclampsia in women with pregestational diabetes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. [2019]