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Clinical Trials/NCT02990767
NCT02990767
Unknown
Not Applicable

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

Shanghai First Maternity and Infant Hospital1 site in 1 country1,000 target enrollmentJune 2016
ConditionsPre-Eclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Eclampsia
Sponsor
Shanghai First Maternity and Infant Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Early preeclampsia
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2019
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Early preeclampsia

Time Frame: 1 year

Secondary Outcomes

  • Selective intrauterine fetal growth restriction(1 year)

Study Sites (1)

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