Aspirin for Pre-eclampsia Prevention

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Virginia

Must be taking: Aspirin

Disqualifiers: ASA allergy, Nasal polyps, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 41 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a higher dose of aspirin could better prevent preeclampsia, a pregnancy condition marked by high blood pressure and potential organ damage. Participants will receive either a low dose (81 mg) or a higher dose (162 mg) of aspirin to determine which is more effective. Pregnant individuals in their first trimester, identified as at risk for preeclampsia by certain screening tests, may be suitable candidates. The findings could lead to improved prevention strategies in the future. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that low-dose aspirin, such as the 81 mg used in this study, is generally safe for pregnant women. It is often recommended for those at high risk of preeclampsia, a condition characterized by high blood pressure during pregnancy. Studies have shown that taking 81 mg daily can reduce the risk of developing this condition without major side effects.

For the 162 mg dose, research also supports its safety. A review found that doses between 150 to 162 mg can more effectively lower the risk of early preeclampsia compared to lower doses. Both doses are considered unlikely to cause serious problems for either the mother or the baby.

In summary, previous studies have shown that both doses of aspirin used in this trial are safe and well-tolerated for pregnant women. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using aspirin for pre-eclampsia prevention because it offers a simple yet potentially powerful approach to reducing risk during pregnancy. Unlike the standard treatment, which might not specifically target early identification of pre-eclampsia risk, aspirin may help by improving blood flow and reducing inflammation, which are key factors in pre-eclampsia. With two different dosages being studied—162 mg and 81 mg—researchers are investigating which dose is most effective for different risk profiles, potentially offering a more personalized preventive strategy. This trial could lead to more tailored prevention methods, improving outcomes for both mothers and babies.

What evidence suggests that this trial's treatments could be effective for preeclampsia?

Research shows that taking a low-dose aspirin, such as 81 mg daily, can lower the risk of preeclampsia, a condition causing high blood pressure during pregnancy. Studies have found it can reduce the chance of developing preeclampsia and related issues by about 10-20%. In this trial, participants will receive either 81 mg or 162 mg of aspirin. Some research suggests that increasing the dose to 162 mg might further decrease the risk, particularly for early-onset preeclampsia, which occurs before 34 weeks of pregnancy. This higher dose has been linked to a significant reduction in early preterm preeclampsia. Both doses are generally considered safe and can offer benefits without increasing the risk of major bleeding during pregnancy. ^{1 3 4 6 7}

Who Is on the Research Team?

Priyanka Kumar

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-50 in their first trimester who may be at low or high risk of developing preeclampsia, as determined by ACOG and FMF tools. Participants must be able to take oral medication, comply with study procedures, and have a prenatal ultrasound between 11+0 through 13+6 days of gestation.

Inclusion Criteria

Provision of signed and dated informed consent form

I am pregnant and in my first trimester.

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

ASA allergy, known hypersensitivity to NSAIDS

Patients with aspirin-induced asthma exacerbations

Non-viable pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks

1 visit (in-person)

Treatment

Participants receive either 81 mg/day or 162 mg/day aspirin from before 14 weeks gestation age through delivery

Up to 41 weeks

Regular visits for ultrasound and blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maternal and fetal outcomes

Up to 6 weeks postpartum

Postpartum visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin 162Mg Ec Tab
• Aspirin 81Mg Ec Tab

Trial Overview The trial is testing the effects of two different daily doses of aspirin (81 mg vs. 162 mg) on preventing preterm preeclampsia in high-risk patients. It's an open-label study where participants are randomly assigned to one of four groups to see if a higher dose has better outcomes.

How Is the Trial Designed?

Group I: 3 Standard of Care Group Experimental Treatment 1 Intervention

Group 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care.

Group II: 2 Randomized Group 1 Active Control 2 Interventions

Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.

Group III: Group 4 Randomized Group 2 Active Control 2 Interventions

Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.

Group IV: 1 Control Group Active Control 1 Intervention

Control Group (Group 1): These patients will be screened negative for both the ACOG screening test and the FMF preeclampsia screen. These women will receive no aspirin.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Aspirin is recommended for women at risk of preeclampsia, with guidelines suggesting initiation between 11 to 28 weeks of gestation, and dosages varying from 75 mg to 150 mg depending on the level of risk.

Evidence indicates that higher doses of aspirin (greater than 100 mg daily) started before 16 weeks of gestation may be more effective in reducing the risk of preeclampsia, highlighting the need for further randomized control trials to determine optimal dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin therapy for the prevention of preeclampsia: time to reconsider our recommendations? Horgan, R., Hage Diab, Y., Waller, J., et al.[2023]

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]

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]

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 of 3,597 patients at risk for preeclampsia, those taking 162 mg of aspirin had a significantly lower rate of preeclampsia (10.1%) compared to those taking the standard 81 mg dose (14.2%).

The higher 162 mg dose did not increase the risk of bleeding complications, suggesting it may be a safer and more effective option for preeclampsia prophylaxis in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Aspirin 162 mg for Preeclampsia Prophylaxis in High-Risk Patients. Ayyash, M., Goyert, G., Garcia, R., et al.[2023]

The new buffered acetylsalicylic acid (ASA) formulation showed equivalent bioavailability to the plain ASA tablet, with a relative bioavailability of 102.49%, indicating it can be used interchangeably with the standard formulation.

Buffered ASA reached peak plasma concentration significantly faster (28 minutes) compared to the plain tablet (38 minutes), suggesting quicker absorption and potentially faster onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic study of a new oral buffered acetylsalicylic acid (ASA) formulation in comparison with plain ASA in healthy volunteers. Viganò, G., Garagiola, U., Gaspari, F.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030847/

Application of low dose aspirin in pre-eclampsia - PMC The results showed that low-dose aspirin could prevent the occurrence of pre-eclampsia in multiple pregnancies but had no effect on the incidence of small for ...

2. 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 ...

3. 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 ...

4. preeclampsia.org preeclampsia.org/aspirin

Ask About Aspirin Research studies are also currently looking at whether 81 or 162-mg doses are more effective. ... Aspirin and Prevention of Preeclampsia: Updated Recommendations.

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32835720/

Prevention of preeclampsia with aspirin The first possible link between the use of aspirin and the prevention of preeclampsia was suggested by a case report published in 1978, followed ...

7. psbchealthhub.ca psbchealthhub.ca/clinical-guidance/816

Low-Dose ASA for the Prevention of Preeclampsia Currently, 81 or 162 mg are acceptable choices. However, a daily dose of 81 mg may maximize maternal safety. Scroll Arrow Icon.