Prediction of Preeclampsia by Comprehensive Markers.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03665623

Enrollment

11741

Registered

2018-09-11

Start date

2017-12-01

Completion date

2020-08-31

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

preeclampsia prediction, competing risk model, 11~13+6 gestational weeks

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results