Prediction of Preeclampsia by Comprehensive Markers.

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

detection rate of preterm preeclampsia at fixed false positive rate 5%,10%,15%,20%

Time frame: 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 outcomes

detection rate of small for gestational neonates at fixed risk cut of defined in primary outcome

Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

A Prospective Multi-center Study on the Prediction of Preeclampsia by Comprehensive Markers in Early Pregnancy.

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Sep 11, 2018
Registry last updated: Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed