Maternal Serum Markers Predicting Preeclampsia at Early Gestations

Preeclampsia Clinical Trial

Official title:

A Case-control Study to Investigate Serum Markers in Predicting Preeclampsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05131282
• Other study ID #: PE_001
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

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