Prediction of Preeclampsia by Comprehensive Markers.

Completed

• Conditions: Pre-Eclampsia

• Registration Number: NCT03665623
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery. Series studies has show that the competing risk model developed by the Fetal Maternal FouNdation in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. We aim to evaluate the performance of various screening model based on FMF model in Chinese population.

Detailed Description

The prospective multi-center observational study aimed to recruit at least 10,000 pregnant woman during the first trimester conducted among 12 medical centers in China. The medical history of each candidate was recorded , blood pressure was measured , blood sample was taken between 11 gestational weeks and 13+6 gestational weeks, to get the PlGF and PAPPA tested. Routine ultrasound was taken with measurement of the uterine artery pulsatility index. The results of the recruited patients were not released to the patients or the doctor. Pregnancy outcome was recorded as to whether the women develop preeclampsia , the SGA babies, or low birth Apgar score and other preeclampsia related adverse maternal and neonatal outcomes. The basic medical information, the mean artery pressure, the PlGF and PAPPA MOM, the UtA PI were used in combination to do the risk stratification, and to develop prediction model for Chinese people.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-09-08
• Study First Posted: 2018-09-11
• Primary Completion: 2019-12-30
• Study Completion: 2020-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-28
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11741

Inclusion Criteria

1. gestational weeks between 11~13+6
2. agreed to participate the study
3. live fetus at recruitment.

Exclusion Criteria

1. first obstetric visit beyond 14 gestational weeks
2. artificial abortion or spontaneous abortion before 20 weeks or lost to follow-up.
3. refused to participate the study.
4. fetus with major chromosome or structural abnormality

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection rate of preterm preeclampsia at fixed false positive rate 5%,10%,15%,20%	at delivery and reviewed 60 days postpartum	PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists.

Secondary Outcome Measures

Name	Time	Method
detection rate of small for gestational neonates at fixed risk cut of defined in primary outcome	at delivery	defined as birthweight above or below the 90th and 10th centiles of our local population standard chart after adjusting for gender and gestation

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China