NCT04021680

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

July 14, 2019

Last Update Submit

March 27, 2023

Conditions

Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of this screening program to detect preeclampsia

    5 years

Interventions

pre-eclampsia screening programOTHER

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

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant woman
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with with singleton pregnancy

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+88689667000smhsiao2@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Obstetrics & Gynecology, Associate Professor

Study Record Dates

First Submitted

July 14, 2019

First Posted

July 16, 2019

Study Start

June 10, 2019

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)