Preeclampsia
Conditions
Keywords
preeclampsia, aspirin, prediction, intervention, PAPP-A, PIGF, sFlt
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.
Interventions
DRUGAspirin
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time and type of delivery | within 24 hours after the delivery | gestational week, vaginal delivery and cesarean section |
| 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 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 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 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 hypertensive disorder during pregnancy | through study completion, an average of 1 year | gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| birth weight of newborn | delivery time | macrosomia, normal weight, low birth weight |
Contacts
Primary ContactJinsong Gao, PhD
Outcome results
None listed