NCT04021680

Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Far Eastern Memorial Hospital

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-eclampsia

Interventions

Type	Name	Description
OTHER	pre-eclampsia screening program	This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.

Timeline

• Start date: 2019-06-10
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2019-07-16
• Last updated: 2023-03-29

Locations

1 site across 1 country: Taiwan