Prediction of Preeclampsia by Comprehensive Markers.

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia

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 Type: Observational
• Enrollment (Actual): 11741

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

we aimed to recruit as many as possible the women without discrimination during the study periods.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: September 8, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 28, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: preeclampsia prediction; competing risk model; 11~13+6 gestational weeks
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: preeclampsia prediction study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No