The Effectiveness of Aspirin on Preventing Pre-eclampsia
Primary Purpose
Pre-Eclampsia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Eclampsia focused on measuring Pre-eclampsia, Aspirin
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
75mg
100mg
blank
Arm Description
Take 75mg of aspirin daily in tihis group
Take 100mg of aspirin daily in this group
Not taking aspirin in this group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Preterm birth
Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
Fetal growth restriction
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
Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
Postpartum hemorrhage
Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
Full Information
NCT ID
NCT04656665
First Posted
November 11, 2020
Last Updated
March 9, 2021
Sponsor
The Third Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04656665
Brief Title
The Effectiveness of Aspirin on Preventing Pre-eclampsia
Official Title
The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
December 14, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
Keywords
Pre-eclampsia, Aspirin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
75mg
Arm Type
Experimental
Arm Description
Take 75mg of aspirin daily in tihis group
Arm Title
100mg
Arm Type
Active Comparator
Arm Description
Take 100mg of aspirin daily in this group
Arm Title
blank
Arm Type
No Intervention
Arm Description
Not taking aspirin in this group
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid
Intervention Description
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Primary Outcome Measure Information:
Title
Incidence of pre-eclampsia
Description
Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Preterm birth
Description
Record the number of preterm in each group and compare whether there are statistical differences in the incidence of each group
Time Frame
1 year
Title
Fetal growth restriction
Description
Record the number of FGR in each group and compare whether there are statistical differences in the incidence of each group
Time Frame
1 year
Title
Placental abruption 4/5000 Placental abruption
Description
Record the number of placental abruption in each group and compare whether there are statistical differences in the incidence of each group
Time Frame
1 year
Title
Postpartum hemorrhage
Description
Record the number of postpartum hemorrhage in each group and compare whether there are statistical differences in the incidence of each group
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang He, Dr.
Phone
+86020-81292532
Email
hefangjnu@126.com
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Aspirin on Preventing Pre-eclampsia
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