The Effectiveness of Aspirin on Preventing Pre-eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-12-31

Brief Summary

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This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

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Detailed Description

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Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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75mg

Take 75mg of aspirin daily in tihis group

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy

100mg

Take 100mg of aspirin daily in this group

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy

blank

Not taking aspirin in this group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin

For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy

Intervention Type DRUG

Other Intervention Names

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Acetylsalicylic acid

Eligibility Criteria

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Inclusion Criteria

* Age between 18-55 years
* Gestational age between 12-20 weeks of pregnancy
* High risk of developing pre-eclampsia

* At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
* At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.
* Maternal informed conset obtained

Exclusion Criteria

* Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
* Patient with known intention to terminate pregnancy
* Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
* Severe heart, liver, renal disease who can not burden the experiment
* Alcohol and drug abuse
* Being in another drug experiment within 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes