Low Dose Aspirin in the Prevention of Preeclampsia in China

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin
* Other: Blank


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 12+ and 20 weeks of pregnancy 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）. Signed informed consent. Exclusion Criteria: Allergy to aspirin Asthma Peptic ulcers Severe heart, liver, renal disease who can not burden the experiment Rheumatic immune disease Mental disease Alcohol and drug abuse Being in another drug experiment within 3 months Difficult to follow-up

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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No

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: aspirin<br>Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night. | Drug: Aspirin<br>* Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.<br>* Other names: acetyl salicylic acid;|
| Other: blank<br>Routine examination during pregnancy. | Other: Blank<br>* Routine examination during pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of preeclampsia | The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of preeclampsia at term | The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy. | 6 months | 
| Fetal Growth Restriction | 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. | 6 months | 
| Preterm birth |  | 6 months | 
| Abruptio placenta | The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy. | 6 months | 
| Maternal hemorrhage and neonatal intracranial hemorrhage |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, low dose aspirin, prevention