Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Far Eastern Memorial Hospital

Status: Enrolling

Conditions: Pre-eclampsia

Treatments: Other: pre-eclampsia screening program

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04021680

108051-F

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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