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

Phase 4

• Conditions: Preeclampsia
• Interventions: Drug: Aspirin

• Registration Number: NCT04631627
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-07
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study Start: 2020-11-16
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-12-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin group	Aspirin	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.
control group	Aspirin	with no intervention

Primary Outcome Measures

Name	Time	Method
the rate of preeclampsia	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	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	through study completion, an average of 1 year	gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome
the rate of placenta abruption	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	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	within 24 hours after the delivery	gestational week, vaginal delivery and cesarean section

Secondary Outcome Measures

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