Preeclampsia
Conditions
Keywords
preeclampsia, low dose aspirin, prevention
Brief summary
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin in Chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.
Detailed description
Detailed Description: The investigators will conduct a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in Chinese pregnant women who are evaluated with risk factors. The investigators will also obtain biological specimen including maternal blood, cord blood, placenta specimen and etc. for basic science studies. Rationale for Design:There is a lack of evidences or guideline of aspirin using in preventing PE for Chinese women. The investigators will conduct a randomized control trial, which is the 'gold standard' of research design, hoping to answer the question.
Interventions
DRUGAspirin
Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.
OTHERBlank
Routine examination during pregnancy.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Gestational age between 12+ and 20 weeks of pregnancy 2. High risk of preeclampsia, based in clinical risk factors as: 2.1 if they have one or more of the following risk factors： Preeclampsia in a previous pregnancy ,Diabetes Mellitus(Type 1 or 2),Chronic Hypertension . 2.2 if they have two or more of the following risk factors: Pre-pregnancy Body Mass Index ≥28kg/m2, Elderly pregnancy(age ≥35 years), Mother or sisters with preeclampsia in a previous pregnancy, Primiparity or Famliy history (Mother or sister that developed preeclampsia in a previous pregnancy）. 3. Signed informed consent.
Exclusion criteria
1. Allergy to aspirin 2. Asthma 3. Peptic ulcers 4. Severe heart, liver, renal disease who can not burden the experiment 5. Rheumatic immune disease 6. Mental disease 7. Alcohol and drug abuse 8. Being in another drug experiment within 3 months 9. Difficult to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of preeclampsia | 6 months | The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of preeclampsia at term | 6 months | The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy. |
| Fetal Growth Restriction | 6 months | The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy. |
| Preterm birth | 6 months | — |
| Abruptio placenta | 6 months | The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy. |
| Maternal hemorrhage and neonatal intracranial hemorrhage | 6 months | — |
Countries
China
Outcome results
None listed