Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

NCT ID: NCT04021680

Last Updated: 2023-03-29

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-10

Study Completion Date

2025-06-20

Brief Summary

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To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Detailed Description

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The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.

In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Conditions

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Pre-eclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pre-eclampsia screening program

This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.

Exclusion Criteria

* Women who are not regularly inspected or not receiving prenatal care in this institution.
* Women who received first trimester pre-eclampsia screening test at other institution
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynecologic Oncology Group

NETWORK

Sponsor Role collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Head of Department of Obstetrics & Gynecology, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Mou Hsiao, MD

Role: CONTACT

+88689667000 ext. 1818

Facility Contacts

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Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1818

Other Identifiers

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108051-F

Identifier Type: -

Identifier Source: org_study_id

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