Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Far Eastern Memorial Hospital

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04021680

Enrollment

2000

Registered

2019-07-16

Start date

2019-06-10

Completion date

2025-06-20

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia

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.

Interventions

OTHERpre-eclampsia screening program

This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Countries

Taiwan

Contacts

Primary ContactSheng-Mou Hsiao, MD

smhsiao2@gmail.com+88689667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026