Prediction of Preeclampsia by Comprehensive Markers.

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665623
• Other study ID #: preeclampsia prediction study
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11741
• Est. completion date: August 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate of preterm preeclampsia at fixed false positive rate 5%,10%,15%,20%	PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists.	at delivery and reviewed 60 days postpartum
Secondary	detection rate of small for gestational neonates at fixed risk cut of defined in primary outcome	defined as birthweight above or below the 90th and 10th centiles of our local population standard chart after adjusting for gender and gestation	at delivery