A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort
Overview
- Phase
- Phase 4
- Intervention
- Aspirin
- Conditions
- Preeclampsia
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 1500
- Primary Endpoint
- the rate of preeclampsia
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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)
Arms & Interventions
aspirin group
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.
Intervention: Aspirin
control group
with no intervention
Intervention: Aspirin
Outcomes
Primary Outcomes
the rate of preeclampsia
Time Frame: through study completion, an average of 1 year
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.
the rate of fetal growth restriction
Time Frame: through study completion, an average of 1 year
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
the rate of hypertensive disorder during pregnancy
Time Frame: through study completion, an average of 1 year
gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome
the rate of placenta abruption
Time Frame: through study completion, an average of 1 year
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
the rate of postpartum hemorrhage
Time Frame: within 24 hours after the delivery
Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml
the time and type of delivery
Time Frame: within 24 hours after the delivery
gestational week, vaginal delivery and cesarean section
Secondary Outcomes
- birth weight of newborn(delivery time)
- Apgar score for newborns(delivery time)
- the rate of Neonatal NICU occupancy rate(through study completion, an average of 1 year)