MedTrace Logo

Maternal Serum Markers Predicting Preeclampsia At Early Gestations

NCT05131282 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18000

Last updated 2024-11-25

No results posted yet for this study

Summary

This observational study aims to assess the effectiveness of a maternal blood test as a prognostic tool for predicting early pregnancy risk of preeclampsia (PE).

We hypothesize that specific circulating protein markers may serve as reliable biomarkers for PE risk prediction. Our PE predictor is a standalone blood test designed for early gestation screening to identify pregnancies at risk. This test measures concentrations of four proteins between 11 weeks and 13 weeks+6 days of gestation.

Based on the levels of these analytes, the test generates a risk score to classify patients as either low or high risk for PE.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood test of PE risk

A blood test is applied to women between 11weeks and 13 weeks+6 days of GA at the first visit to evaluate risk of developing PE

DIAGNOSTIC_TEST

Blood test of Preterm PE risk

A blood test is applied to women between 11 weeks and 13 weeks+6 days of GA at the first visit to evaluate risk of developing Preterm PE

Sponsors & Collaborators

  • Shenzhen Maternity & Child Healthcare Hospital

    collaborator OTHER

  • Eighth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Women's Hospital, of Zhejiang University School of Medicine

    collaborator UNKNOWN

  • Third Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Hunan Provincial Maternal and Child Health Care Hospital

    collaborator OTHER

  • HBI Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Jianmin Niu, Master · Shenzhen Maternity and Child Healthcare Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131282 on ClinicalTrials.gov