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

150 Participants Needed

Trial Summary

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 evidence supports the effectiveness of aspirin as a drug for preventing pre-eclampsia?

Research shows that low-dose aspirin can reduce the risk of pre-eclampsia by about 25% in high-risk pregnant women. It is considered safe for both the mother and baby when used in low doses. ^{1 2 3 4 5}

Is low-dose aspirin safe for preventing pre-eclampsia in pregnant women?

Research indicates that low-dose aspirin is generally safe for pregnant women, their fetuses, and newborns when used to prevent pre-eclampsia, with no significant increase in bleeding risks. Large studies have shown that it does not significantly increase the risk of placental issues or bleeding during delivery. ^{1 2 3 6 7}

How does aspirin differ from other drugs for preventing pre-eclampsia?

Aspirin, particularly at a higher dose of 162 mg, is being studied for its potential to prevent pre-eclampsia in high-risk pregnancies, which may offer more efficacy compared to the standard 81 mg dose. This approach is unique as it targets high-risk patients early in pregnancy, aiming to reduce the incidence of early-onset pre-eclampsia. ^{1 2 3 7 8}

What is the purpose of this trial?

This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.

Research Team

Priyanka Kumar

Principal Investigator

University of Virginia

Eligibility Criteria

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

Non-viable pregnancy

I have nasal polyps.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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]

References

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

The pharmacological prevention of pre-eclampsia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Low-dose aspirin therapy in obstetrics. [2019]

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

Efficacy and Safety of Aspirin 162 mg for Preeclampsia Prophylaxis in High-Risk Patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled study of the effect of low dose aspirin on platelet reactivity and serum thromboxane B2 production in non-pregnant women, in normal pregnancy, and in gestational hypertension. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic study of a new oral buffered acetylsalicylic acid (ASA) formulation in comparison with plain ASA in healthy volunteers. [2013]

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

Low-dose aspirin therapy for the prevention of preeclampsia: time to reconsider our recommendations? [2023]

7. England pubmed.ncbi.nlm.nih.gov

CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. [2017]

8. 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]