Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Far Eastern Memorial Hospital

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

Study Overview

• Status: Recruiting
• Conditions: Pre-eclampsia
• Intervention / Treatment: Other: pre-eclampsia screening program

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Sheng-Mou Hsiao, MD; Phone Number: 1818 +88689667000; Email: smhsiao2@gmail.com

Study Locations

• Taiwan
  • New Taipei
    • Banqiao, New Taipei, Taiwan, 22050
      • Recruiting
      • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women with with singleton pregnancy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity of this screening program to detect preeclampsia	5 years

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Anticipated): June 20, 2025
• Study Completion (Anticipated): June 20, 2025

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 14, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 108051-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No