Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Recruiting

• Conditions: Pre-eclampsia

• Registration Number: NCT04021680
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-07-14
• Study First Posted: 2019-07-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of this screening program to detect preeclampsia	5 years

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan