The Effectiveness of Aspirin on Preventing Pre-eclampsia

Study Overview
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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.

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.

Official Title
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The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 75mg<br>Take 75mg of aspirin daily in tihis group | Drug: Aspirin<br>* For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy<br>* Other names: Acetylsalicylic acid;|
| Active Comparator: 100mg<br>Take 100mg of aspirin daily in this group | Drug: Aspirin<br>* For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy<br>* Other names: Acetylsalicylic acid;|
| No Intervention: blank<br>Not taking aspirin in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pre-eclampsia | Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group | 1 year | 
| Fetal growth restriction | Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group | 1 year | 
| Placental abruption 4/5000 Placental abruption | Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group | 1 year | 
| Postpartum hemorrhage | Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia, Aspirin