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NCT02990767 Clinical Trial

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

Pre-Eclampsia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02990767
Other study ID # ShanghaiFMIH-FMU3
Secondary ID
Status Recruiting
Phase N/A
First received December 9, 2016
Last updated December 9, 2016
Start date June 2016
Est. completion date June 2019

Study information
Verified date December 2016
Source Shanghai First Maternity and Infant Hospital
Contact Luming Sun, PhD
Phone 021-20261151
Email luming_sun@163.com
Is FDA regulated No
Health authority China: Shanghai Municipal Commission of Health and Family Planning
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date June 2019
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Shanghai First Maternity and Infant Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Early preeclampsia 1 year No
Secondary Selective intrauterine fetal growth restriction 1 year No
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