Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Study Overview
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Brief Summary
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This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.

Official Title
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A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks < 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes Exclusion Criteria: 1)with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin group<br>aspirin,tablet,100/150mg per day,(BMI<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks<16 to 35 weeks or the day of delivery. | Drug: Aspirin<br>* With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.<br>|
| Sham Comparator: control group<br>with no intervention | Drug: Aspirin<br>* With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of preeclampsia | Hypertensive onset after 20 weeks of gestation is accompanied by proteinuria,or with thrombocytopenia, impaired liver function, renal insufficiency,pulmonary edema,headache without other explanation and so on. | through study completion, an average of 1 year | 
| the rate of hypertensive disorder during pregnancy | gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome | through study completion, an average of 1 year | 
| the rate of placenta abruption | After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus | through study completion, an average of 1 year | 
| the rate of fetal growth restriction | The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age | through study completion, an average of 1 year | 
| the rate of postpartum hemorrhage | Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml | within 24 hours after the delivery | 
| the time and type of delivery | gestational week, vaginal delivery and cesarean section | within 24 hours after the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight of newborn | macrosomia, normal weight, low birth weight | delivery time | 
| Apgar score for newborns | ≥8；4-7,；≤3 | delivery time | 
| the rate of Neonatal NICU occupancy rate | the day of NICU occupancy | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, aspirin, prediction, intervention, PAPP-A, PIGF, sFlt