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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05131282
Other study ID # PE_001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2022
Est. completion date December 2023

Study information

Verified date March 2022
Source HBI Solutions Inc.
Contact James Shilling, PhD
Phone 650-427-9198
Email admin@mprobe.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to evaluate a blood test that can identify women at high-risk of PE at the 1st or early 2nd trimester.


Description:

PE incidence is 5-8% of all pregnancies in US and worldwide. Morbidity, mortality, and medical legal risks of missing PE often lead to over diagnosis. Currently there is no molecular blood laboratory developed test which can allow serial micro-samplings to assess the PE risk when asymptomatic at home setting along the duration of pregnancy. The hypothesis is that a blood test can predict PE with a sensitivity higher than 85% and a specificity higher than 80% at early gestation in a PE-Normal cohort. A single-site retrospective cohort of women who developed PE and women with normal pregnancy will be recruited. Blood samples have been collected from each subject once at the 1st trimester or early 2nd trimester. Delivery and neonatal data have been collected through chart reviews. Two groups (PE and Normal) are matched with age and clinical conditions. It is an observational study of the accuracy of a diagnostic test on PE prediction. There is only one group of participants. Participants will be tested using a blood test to determine positive or negative. Sensitivity and specificity (Primary outcomes) of the test will be measured at the end of study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having serum collected at a gestational age between 8 and 21 weeks; Exclusion Criteria: - Age less than 18 - Preexisting preeclampsia - Multiple pregnancy or higher order pregnancy - Missing outcome data of PE, including diagnosis date and PE type

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood test of PE risk
A blood test is applied to women at the 1st or early 2nd trimester to evaluate risk of developing PE

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
HBI Solutions Inc. mProbe Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity Sensitivity and specificity of the blood test in classifying PE and normal an average of up to 1 year
Secondary Sensitivity and specificity with the sub-cohorts Sensitivity and specificity of the blood test in classifying PE and normal with the sub-cohorts of a) Early-onset PE, b) Late-onset PE, and c) Severe PE an average of up to 1 year
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