Pre-Eclampsia
Conditions
Keywords
Pre-eclampsia, Aspirin
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.
Interventions
DRUGAspirin
For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactFang He, Dr.
Outcome results
None listed