Prediction of Early Pre-eclampsia From Maternal Factors, Biophysical and Biochemical Markers at First Trimester

• Conditions: Pre-Eclampsia

• Registration Number: NCT02990767
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

The aims of this study are to develop algorithms based on a combination of maternal factors, uterine artery PI, MAP and serum biomarkers to estimate patient-specific risks for early Preeclampsia (PE) and to evaluate the screening performance of such algorithms in twins.

Detailed Description

Preeclampsia (PE) is still a leading cause of fetal and maternal morbidity and mortality with an incidence of 3-5% worldwide. Despite intensive research efforts the pathogenesis of the disease is still unknown but it is likely to be multifactorial.Clinical risk factors traditionally have been used to identify women at high risk of developing preeclampsia,and biophysical factors that may help predict hypertensive disorders of pregnancy.In addition,changes in the serum concentrations of angiogenic and antiangiogenic factors are implied in the pathogenesis of PE and have possible relevance in the diagnosis of the disease.

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-12
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-09
• Study First Posted: 2016-12-13
• Last Update Posted: 2016-12-13
• Primary Completion: 2017-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• twins pregnancies delivering a phenotypically normal stillbirth or live birth at or after 24 weeks of gestation.
• twins pregnancies at at 11-14 weeks of gestation

Read More

Exclusion Criteria

• pregnancies with major fetal abnormalities and those ending in termination, miscarriage or fetal death before 24 weeks

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early preeclampsia	1 year

Secondary Outcome Measures

Name	Time	Method
Selective intrauterine fetal growth restriction	1 year

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China