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RecruitingNCT04021680Updated Mar 29, 2023

Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

An observational study in Pre-eclampsia, sponsored by Far Eastern Memorial Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
20 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pre-eclampsia
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

women with with singleton pregnancy

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

  • Otherpre-eclampsia screening program

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

05

What researchers measure

Primary outcomes

  1. The sensitivity and specificity of this screening program to detect preeclampsia

    Time frame: 5 years

06

Study locations

1 of 1 sites recruiting
  • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
    Banqiao, New Taipei 22050, Taiwan
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04021680
Lead sponsor
Far Eastern Memorial Hospital
Collaborators
Gynecologic Oncology Group
Responsible party
Sheng-Mou Hsiao (Head of Department of Obstetrics & Gynecology, Associate Professor, Far Eastern Memorial Hospital) — Principal investigator
First posted
Jul 16, 2019
Start date
Jun 10, 2019
Primary completion
Jun 20, 2025 (estimated)
Completion
Jun 20, 2025 (estimated)
Last update
Mar 29, 2023

Study contacts

Sheng-Mou Hsiao, MD
Contact
smhsiao2@gmail.com
+88689667000 ext. 1818

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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