Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Last updated: March 27, 2023
Sponsor: Far Eastern Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT04021680
108051-F
  • Ages > 20
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Women who are not regularly inspected or not receiving prenatal care in thisinstitution.
  • Women who received first trimester pre-eclampsia screening test at other institution

Study Design

Total Participants: 2000
Study Start date:
June 10, 2019
Estimated Completion Date:
June 20, 2025

Study Description

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.

Connect with a study center

  • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

    Banqiao, New Taipei 22050
    Taiwan

    Active - Recruiting

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