Low-Dose Aspirin for Preeclampsia

(TAP Trial)

Overseen By Sila Yavan, MS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Alisse Hauspurg

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking low-dose aspirin after childbirth can improve blood vessel health and lower blood pressure in individuals who experienced preeclampsia, a pregnancy complication involving high blood pressure. Researchers compare aspirin with a placebo (a pill with no medicine) to determine which is more effective. Ideal participants are those who have recently given birth and were diagnosed with preeclampsia. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

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 is the safety track record for low-dose aspirin?

Research shows that low-dose aspirin is generally safe, particularly for preventing preeclampsia, a condition where pregnant women develop high blood pressure. Studies have found that low-dose aspirin does not increase the risk of serious side effects for mothers, unborn babies, or newborns.

Low-dose aspirin has been widely studied and used during pregnancy to help prevent preeclampsia. Evidence does not indicate an increased risk of major bleeding, a common concern with aspirin. Overall, this treatment is well-tolerated and has been safely used in pregnant women to reduce the risk of complications. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for preeclampsia, which often focus on managing symptoms and controlling blood pressure, low-dose aspirin offers a preventive approach. It’s unique because it targets the underlying inflammation and blood clotting issues associated with preeclampsia. Researchers are excited about this treatment because it’s simple, inexpensive, and could potentially reduce the risk of preeclampsia developing in the first place, which would be a game-changer for maternal and fetal health.

What evidence suggests that low-dose aspirin might be an effective treatment for preeclampsia?

Research has shown that taking low-dose aspirin during pregnancy can help prevent preeclampsia, a condition affecting blood pressure. Studies have found that aspirin use can reduce fetal growth problems related to preeclampsia by 10–20%. Specifically, taking aspirin is linked to a 17% lower chance of developing preeclampsia compared to not taking it. In this trial, participants in the intervention group will receive a low-dose aspirin pill daily for six months. While most research focuses on prevention, these findings suggest that aspirin might also help manage blood pressure and blood vessel health. This could be important for improving blood vessel function and lowering blood pressure after experiencing preeclampsia. ^{1 3 4 6 7}

Who Is on the Research Team?

Alisse Hauspurg, MD

Principal Investigator

UPMC Magee Women's Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Low-dose aspirin

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Aspirin for:

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

Approved in European Union as Acetylsalicylic acid for:

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

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

In a study involving 898 high-risk pregnant women in China, taking 100 mg of low-dose aspirin daily did not significantly reduce the incidence of preeclampsia compared to a control group, with rates of 16.8% in the aspirin group and 17.1% in the control group.

The study also found no significant differences in adverse maternal and neonatal outcomes between the aspirin and control groups, suggesting that low-dose aspirin may not be effective for preeclampsia prevention in this population.

NCBI (Pubmed)

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. Lin, L., Huai, J., Li, B., 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12309040/

Effectiveness of low-dose aspirin in reducing the risk ...

Aspirin 150 mg was introduced before 11 weeks of gestation. The results showed a non-significant reduction in the incidence of preeclampsia.

2.

acog.org

acog.org/clinical/clinical-guidance/committee-opinion/articles/2018/07/low-dose-aspirin-use-during-pregnancy

Low-Dose Aspirin Use During Pregnancy

Systematic reviews of low-dose aspirin when used in the setting of preeclampsia prevention have consistently reported a 10–20% reduction in fetal growth ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04070573

Low Doses of Aspirin in the Prevention of Preeclampsia

Taking ASA (as opposed to placebo) is thought to reduce the risk of preeclampsia by 17%, without increasing the risk of major obstetric bleeding. The number ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589933323001428

Systematic Review Comparing aspirin 75 to 81 mg vs 150 ...

The pooled analysis demonstrated that an aspirin dosage of 150 to 162 mg was associated with a significant reduction of preterm preeclampsia, compared with an ...

5.

preeclampsia.org

preeclampsia.org/aspirin

Ask About Aspirin

Low-dose aspirin initiated after 16 weeks' gestation may not be as effective at reducing the risk of preeclampsia, severe preeclampsia, and fetal growth ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589933325001673

Maternal, fetal, and neonatal serious adverse events ...

Low-dose aspirin initiated in early pregnancy is not associated with increased risks of serious adverse events for mothers, fetuses, or neonates. Evidence ...

7.

uspreventiveservicestaskforce.org

uspreventiveservicestaskforce.org/uspstf/recommendation/low-dose-aspirin-use-for-the-prevention-of-morbidity-and-mortality-from-preeclampsia-preventive-medication

Aspirin Use to Prevent Preeclampsia and Related ...

The USPSTF found evidence of a reduction in risk for preeclampsia (pooled RR, 0.85 [95% CI, 0.75-0.95]; 16 studies; I2 = 0%) with low-dose ...