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Prediction of Preeclampsia by Comprehensive Markers.

NCT ID: NCT03665623

Last Updated: 2020-12-01

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

COMPLETED

Total Enrollment

11741 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pre-Eclampsia

Keywords

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preeclampsia prediction competing risk model 11~13+6 gestational weeks

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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preeclampsia prediction study

Identifier Type: -

Identifier Source: org_study_id