Aspirin for Preeclampsia

(ASAPP Trial)

Overseen By Ashten B Waks, MD MSPH

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: MemorialCare Health System

Must not be taking: Aspirin

Disqualifiers: Age <18, Chronic hypertension, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking low-dose aspirin for a week after childbirth can aid recovery from severe preeclampsia, a pregnancy-related high blood pressure disorder. Researchers believe aspirin might reduce a protein linked to preeclampsia and help normalize blood pressure more quickly. Participants will receive either standard blood pressure care with aspirin or just standard care. Women who experienced severe preeclampsia during delivery and received specific prenatal care in Long Beach may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are already prescribed aspirin for another condition, you cannot participate in this trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking low-dose aspirin is generally safe during pregnancy. Studies have found that a daily dose of 81 mg carries a low risk of serious problems for both mother and baby. This dose is often recommended to help prevent preeclampsia, a condition characterized by high blood pressure during pregnancy. Although limited safety information exists for higher doses, the 81 mg dose is well-researched and commonly prescribed to pregnant individuals at high risk for preeclampsia. Thus, low-dose aspirin is a well-tolerated option for managing this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for preeclampsia?

Researchers are excited about using aspirin for preeclampsia because it offers a simple and potentially effective way to manage postpartum blood pressure. Unlike standard care that primarily focuses on controlling blood pressure through medication, aspirin, a common anti-inflammatory and blood thinner, could aid in preventing complications associated with preeclampsia. The ease of taking a low-dose aspirin by mouth for just one week post-delivery makes it an accessible and straightforward option. This approach could provide an additional benefit to standard blood pressure control methods, potentially improving outcomes for new mothers.

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

Research shows that low-dose aspirin can help reduce the risk of developing preeclampsia, a condition during pregnancy. Studies have found that aspirin lowers the chances of preeclampsia by about 17% in people at high risk. In this trial, one group of participants will receive standard blood pressure control plus 81 mg of aspirin, which might aid recovery after childbirth by managing certain proteins related to the condition and lowering blood pressure. While most research focuses on preventing preeclampsia during pregnancy, the same process might assist with recovery. Overall, aspirin is generally considered safe and effective for addressing issues related to preeclampsia. ^{1 6 7 8 9}

Who Is on the Research Team?

Megan C Oakes, MD MSCI

Principal Investigator

Miller Children's and Women's Hospital, Long Beach/ MemorialCare Medical Center

Are You a Good Fit for This Trial?

This trial is for women who have just given birth and were diagnosed with severe preeclampsia during delivery. They must be receiving care from the Long Beach Memorial Ob/Gyn or Maternal-Fetal Medicine clinic.

Inclusion Criteria

I was diagnosed with severe preeclampsia during my delivery.

You receive prenatal and postnatal care from the Long Beach Memorial Ob/Gyn resident or Maternal-Fetal Medicine clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard postpartum blood pressure control with or without aspirin 81 mg for 1 week post-delivery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure normalization and safety outcomes

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin

Trial Overview The study is testing if low-dose aspirin can help women recover faster from severe preeclampsia after childbirth by lowering a protein linked to high blood pressure in pregnancy.

How Is the Trial Designed?

Group I: Standard blood pressure control plus aspirin 81 mg Experimental Treatment 1 Intervention

Standardized postpartum blood pressure control Aspirin 81 mg by mouth x 1 week post-delivery

Group II: Standard blood pressure control Active Control 1 Intervention

Standardized postpartum blood pressure control

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

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

Approved in United States as Aspirin for:

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

Approved in Canada as Aspirin for:

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

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

MemorialCare Health System

Lead Sponsor

Trials

21

Recruited

2,600+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211524006006

The effectiveness of low-dose aspirin for the prevention of ... Low-dose aspirin of 162 mg reduces the frequency of preeclampsia. •. Prescribe aspirin between 12 and 20 weeks and stop at 36 weeks gestational age.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2784499

Aspirin Use to Prevent Preeclampsia and Related ... Evidence demonstrates that aspirin use reduces the risk of preeclampsia in high-risk populations. Timing and Dosage. Effective dosages of low-dose aspirin range ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5681618/

Aspirin for Prevention of Preeclampsia - PMC Safety data at 150 mg/day are still limited. Aspirin, in primary prevention of preeclampsia, given to high-risk patients identified in the ...

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 ... For pregnant persons: Prescribe low-dose (81 mg/d) aspirin after 12 weeks of gestation to persons who are at high risk for preeclampsia.

8. mayoclinic.org mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/expert-answers/aspirin-during-pregnancy/faq-20058167

Aspirin during pregnancy: Is it safe? Low-dose aspirin is safe to use throughout pregnancy, and it may be recommended in some situations. Higher doses of aspirin typically are not recommended ...

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

Systematic Review Comparing aspirin 75 to 81 mg vs 150 ... An aspirin dosage of 150 to 162 mg daily was associated with a lower risk of preterm PE than an aspirin dosage of 75 to 81 mg daily.