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

NCT ID: NCT02990767

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Pre-Eclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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observational women

collecting maternal factors, biophysical and biochemical markers at 11-13 weeks of gestation.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luming Sun, PhD

Role: CONTACT

Phone: 021-20261151

Email: [email protected]

Facility Contacts

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Luming Sun, PhD

Role: primary

Other Identifiers

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ShanghaiFMIH-FMU3

Identifier Type: -

Identifier Source: org_study_id