130 Participants Needed

Aspirin for Preeclampsia Prevention

RO
AR
Overseen ByAmihai Rottenstreich, MD
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Rockefeller University
Must be taking: Low-dose aspirin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking non-prescription NSAIDs (like ibuprofen) for one week before certain tests. If you are currently using antithrombotic agents (like aspirin or warfarin), you cannot participate in the trial.

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

Research shows that starting low-dose aspirin early in pregnancy can help prevent preeclampsia, especially when begun before 16 weeks of gestation. Recent studies and reviews suggest it reduces the risk of early-onset preeclampsia and related complications.12345

Is low-dose aspirin safe for preventing preeclampsia?

Low-dose aspirin appears to be safe for pregnant women, their babies, and newborns, based on studies involving over 13,000 women.16789

How is aspirin different from other drugs for preventing preeclampsia?

Aspirin is unique in its ability to prevent preeclampsia by inhibiting the production of thromboxane, a substance that can be elevated in severe cases of the condition. It is most effective when started early in pregnancy, before 16 weeks, and is considered safe for both the mother and fetus at low doses.345810

What is the purpose of this trial?

This trial is testing low-dose aspirin to prevent preeclampsia in pregnant women, especially Black women who may have higher rates of aspirin failure. Aspirin works by preventing blood clots and improving blood flow in the placenta. Low-dose aspirin has been studied for a long time for its potential to prevent preeclampsia, with mixed results.

Research Team

AR

Amihai Rottenstreich, MD

Principal Investigator

Rockefeller University

Eligibility Criteria

This trial is for women aged 18-45 who had preeclampsia in a past pregnancy, took low-dose aspirin before the 16th week of their next pregnancy with at least 80% compliance, and did not have significant health issues like bleeding disorders or chronic hypertension. It's not for those currently pregnant or on blood thinners.

Inclusion Criteria

I am a woman aged 18-45 with a history of preeclampsia and took low dose aspirin in my next pregnancy, regardless of preeclampsia recurrence.
Aspirin was given in their subsequent pregnancy in a 81 mg dose prior to 16 weeks of gestation, and was taken with a self-reported compliance rate of at least 80%
Subsequent pregnancy lasted beyond 20 weeks of gestation
See 2 more

Exclusion Criteria

I have had a bleeding stroke in the past.
Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons
I have had kidney or liver problems.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of enteric-coated 81 mg aspirin to assess platelet response and genetic factors associated with aspirin failure

1 day
1 visit (in-person)

Follow-up

Participants are monitored for platelet response and thromboxane A2 levels at baseline and 1 hour post aspirin administration

1 day
1 visit (in-person)

Genetic Analysis

Allelic frequency of the PAR4 variant (rs773902) is analyzed in relation to aspirin success in preeclampsia prevention

At study enrollment

Treatment Details

Interventions

  • Aspirin
Trial Overview The study looks into why low-dose aspirin sometimes fails to prevent preeclampsia in pregnant women. Researchers are examining genetic factors that might affect how well aspirin works to reduce this risk.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Women with prior history of preeclampsia who received aspirin in subsequent gestationExperimental Treatment1 Intervention
Single-dose of enteric-coated 81 mg aspirin
Group II: Healthy volunteersActive Control1 Intervention
In this group, no aspirin will be given, as blood draw will not be performed at all among the healthy volunteers. The group of healthy volunteers will serve only for the SNP assay development.

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

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡จ๐Ÿ‡ณ
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?

Rockefeller University

Lead Sponsor

Trials
162
Recruited
16,700+

Findings from Research

Aspirin use during pregnancy has been shown to significantly reduce the risk of developing preeclampsia, a serious condition that can lead to complications for both the mother and baby.
The systematic review analyzed updated evidence and supports the recommendation for aspirin as a preventive measure, highlighting its safety and efficacy in reducing related morbidity and mortality.
More evidence for low-dose aspirin in preventing pre-eclampsia.[2022]
Early initiation of low-dose aspirin (60 mg/day) before 17 weeks of pregnancy significantly reduced the risk of late-onset preeclampsia (โ‰ฅ34 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]
Low-dose aspirin, when started before 16 weeks of gestation, has been associated with a reduction in early-onset preeclampsia and lower rates of perinatal death or morbidity, making it a promising preventive treatment.
Heparin may also help prevent preeclampsia due to its antithrombotic and anti-inflammatory properties, but studies show mixed results regarding its effectiveness, indicating more research is needed.
Aspirin vs Heparin for the Prevention of Preeclampsia.Katsi, V., Kanellopoulou, T., Makris, T., et al.[2018]

References

More evidence for low-dose aspirin in preventing pre-eclampsia. [2022]
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]
Aspirin vs Heparin for the Prevention of Preeclampsia. [2018]
Efficacy and Safety of Aspirin 162 mg for Preeclampsia Prophylaxis in High-Risk Patients. [2023]
Leveraging quality improvement to promote health equity: standardization of prenatal aspirin recommendations. [2023]
Low-dose aspirin therapy in obstetrics. [2019]
[The Role of Aspirin in Preeclampsia Prevention: State of the Art]. [2018]
A randomized controlled trial of low-dose aspirin for the prevention of preeclampsia in women at high risk in China. [2022]
Aspirin for Prevention of Preeclampsia. [2019]
Pre-eclampsia. III: The role of aspirin in prevention. [2013]
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