RecruitingPhase 3NCT06111079

Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial


Sponsor

FANG HE

Enrollment

1,800 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial studies when it is safe to stop taking aspirin during pregnancy in women who started it early to prevent preeclampsia (dangerous high blood pressure in pregnancy). **You may be eligible if...** - You started aspirin before 16 weeks of pregnancy with a normal early ultrasound - You have at least one high-risk or two moderate-risk factors for preeclampsia - You plan to deliver at the participating hospital **You may NOT be eligible if...** - You started aspirin after 16 weeks of pregnancy - You are intolerant or allergic to aspirin - Your aspirin adherence was less than 80% - You had a miscarriage or pregnancy termination before the study started - You were lost to follow-up or did not return for delivery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGaspirin discontinuation

Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation.

DRUGaspirin continuation

Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation.


Locations(1)

FANG HE

Guangzhou, Guangdong, China

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NCT06111079


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