The Effectiveness of Aspirin on Preventing Pre-eclampsia
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 75mg Take 75mg of aspirin daily in tihis group |
Drug: Aspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Other Names:
|
Active Comparator: 100mg Take 100mg of aspirin daily in this group |
Drug: Aspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Other Names:
|
No Intervention: blank Not taking aspirin in this group |
Outcome Measures
Primary Outcome Measures
- Incidence of pre-eclampsia [1 year]
Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
Secondary Outcome Measures
- Preterm birth [1 year]
Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
- Fetal growth restriction [1 year]
Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group
- Placental abruption 4/5000 Placental abruption [1 year]
Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
- Postpartum hemorrhage [1 year]
Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18-55 years
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Gestational age between 12-20 weeks of pregnancy
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High risk of developing pre-eclampsia
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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.
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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.
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Maternal informed conset obtained
Exclusion Criteria:
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Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
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Patient with known intention to terminate pregnancy
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Fetal abnormalities detected (including but not limited to major fetal malformation and FGR)
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Severe heart, liver, renal disease who can not burden the experiment
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Alcohol and drug abuse
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Being in another drug experiment within 3 months
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ThirdGuangzhouMU