180 Participants Needed

Aspirin for Preeclampsia

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EH
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Overseen ByColleen Duncan, RN
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.

Will I have to stop taking my current medications?

The trial requires that you do not take any nonsteroidal anti-inflammatory drugs (like ibuprofen) while participating. If you are currently taking these, you will need to stop.

What data supports the effectiveness of the drug aspirin in preventing preeclampsia?

Research shows that taking low-dose aspirin early in pregnancy can help reduce the risk of preeclampsia, a condition that can cause high blood pressure and other problems during pregnancy. Studies have found that aspirin is particularly effective for women at high risk of developing this condition.12345

Is low-dose aspirin safe for pregnant women?

Low-dose aspirin (60-80 mg per day) is generally considered safe for pregnant women and their babies, with no increased risk of bleeding for the mother or fetus observed in studies.678910

How does aspirin differ from other drugs for preeclampsia?

Aspirin is unique for preeclampsia prevention because it is used in low doses and its effectiveness depends on the timing and dosage, with doses over 100 mg daily before 16 weeks of pregnancy being most effective. Unlike other treatments, aspirin is widely studied and recommended by various health organizations, but guidelines on its use vary significantly.611121314

Eligibility Criteria

This trial is for pregnant adults aged 18-45 diagnosed with preeclampsia and expecting one baby. It's not for those planning to deliver outside the study site, involved in other trials, or with conditions like ulcers, bleeding disorders, heart disease, diabetes, kidney issues or multiple pregnancies. Also excluded are those allergic to aspirin or needing NSAIDs.

Inclusion Criteria

Diagnosed with preeclampsia
I am pregnant and between 18 and 45 years old.
Presenting for delivery with a singleton gestation.

Exclusion Criteria

Patients in labor
Co-enrolled in other trials that might affect the patients taking the study medication, as determined by the PI
I have a history of heart, lung, kidney disease, diabetes, or was pregnant with multiples.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants with elevated Activin A levels receive either aspirin therapy or placebo postpartum

6 months
1 visit (in-person) at postpartum delivery stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements of GLS and other cardiac functions

6 months
1 visit (in-person) at 6 months postpartum

Treatment Details

Interventions

  • Aspirin
  • Placebo
Trial OverviewThe trial tests if low-dose aspirin (81 mg) can lower Activin A levels postpartum and improve heart function in women with preeclampsia compared to a placebo. Participants will be randomly assigned to either the aspirin group or placebo group without knowing which they're receiving.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Intervention ArmActive Control1 Intervention
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of aspirin 81 mg.
Group II: Observational ArmActive Control1 Intervention
60 subjects will be placed in the observational arm. These subjects will not receive any intervention but will be followed and asked to return at the same time interval as the other 2 groups.
Group III: Placebo ArmPlacebo Group1 Intervention
60 subjects will be randomly assigned to this arm. The subjects in this arm will receive a daily dose of a placebo pill

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

πŸ‡ͺπŸ‡Ί
Approved in European Union as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
πŸ‡ΊπŸ‡Έ
Approved in United States as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
πŸ‡¨πŸ‡¦
Approved in Canada as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
πŸ‡¨πŸ‡³
Approved in China as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Findings from Research

Early initiation of low-dose aspirin (60 mg/day) before 17 weeks of pregnancy significantly reduced the risk of late-onset preeclampsia (β‰₯34 weeks) by 29% in high-risk women, particularly those with chronic hypertension.
The study, which analyzed data from 523 women enrolled in a high-risk trial, found that aspirin led to a 41% reduction in late-onset preeclampsia rates among women with chronic hypertension, supporting the recommendation for early aspirin use in this population.
Early initiation of low-dose aspirin for reduction in preeclampsia risk in high-risk women: a secondary analysis of the MFMU High-Risk Aspirin Study.Moore, GS., Allshouse, AA., Post, AL., et al.[2018]
A systematic review of four studies involving 392 women found that early administration of low-dose aspirin (started at or before 16 weeks of pregnancy) significantly reduces the risk of severe preeclampsia, with a relative risk of 0.22.
However, the same early aspirin treatment did not show a significant effect on reducing mild preeclampsia, indicating that while it is effective for severe cases, it may not be beneficial for milder forms of the condition.
Early administration of low-dose aspirin for the prevention of severe and mild preeclampsia: a systematic review and meta-analysis.Roberge, S., Giguère, Y., Villa, P., et al.[2018]
In a study of 266 high-risk pregnant women, those who took low-dose aspirin (75 mg daily) had a significantly lower incidence of preeclampsia (10.43%) compared to those who did not take aspirin (22.52%), indicating its efficacy in prevention.
Starting low-dose aspirin before 16 weeks of gestation further enhanced its effectiveness, particularly in women without chronic hypertension, suggesting optimal timing for intervention.
Aspirin 75 mg to prevent preeclampsia in high-risk pregnancies: a retrospective real-world study in China.Xiao, Y., Ling, Q., Yao, M., et al.[2023]

References

Early initiation of low-dose aspirin for reduction in preeclampsia risk in high-risk women: a secondary analysis of the MFMU High-Risk Aspirin Study. [2018]
Early administration of low-dose aspirin for the prevention of severe and mild preeclampsia: a systematic review and meta-analysis. [2018]
Aspirin 75 mg to prevent preeclampsia in high-risk pregnancies: a retrospective real-world study in China. [2023]
Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment with ASpirin for evidence-based PREeclampsia prevention (ASPRE). [2019]
Low-dose aspirin for primary prevention of adverse pregnancy outcomes in twin pregnancies: an observational cohort study based on propensity score matching. [2021]
Low-dose aspirin in primigravidae with positive roll-over test. [2018]
Leveraging quality improvement to promote health equity: standardization of prenatal aspirin recommendations. [2023]
Pre-eclampsia. III: The role of aspirin in prevention. [2013]
-Is prevention of pre-eclampsia with low dosage aspirin possible? Critical assessment of available studies-. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Should we recommend universal aspirin for all pregnant women? [2022]
11.United Statespubmed.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]
12.United Statespubmed.ncbi.nlm.nih.gov
Low-dose aspirin therapy for the prevention of preeclampsia: time to reconsider our recommendations? [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Comparing aspirin 75 to 81 mg vs 150 to 162 mg for prevention of preterm preeclampsia: systematic review and meta-analysis. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Aspirin 162 mg for Preeclampsia Prophylaxis in High-Risk Patients. [2023]