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NCT04456660 Clinical Trial

Comprehensive Assessment of Risks for Miscarriage.

Spontaneous Abortion Clinical Trial

— MIS-CARE  

Official title:
Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04456660
Other study ID # MIS-CARE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2020
Est. completion date December 1, 2023

Study information
Verified date October 2023
Source Orthogyn Medical Center, Bulgaria
Contact Petar N Ignatov, PhD
Phone 0035988896318
Email ignatov@orthogyn.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion

Description:

To study the added value (if any) of combining serum markers, immunologic factors, and ultrasound parameters in comprehensively evaluating the risk for spontaneous abortion.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 1, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - visualized fetal structures in utero & heart pulsations until 8th week of gestation - normal THS/T4 levels - no uterine malformations - BMI < 27 - signed informed consent Exclusion Criteria: - fetal structures in utero & heart pulsations not visualized until the 8th week of gestation - elevated THS/T4 levels - uterine malformations - BMI > 27

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Markers of ultrasound
CRL, HR, and other ultrasound measurements.
• Immunologic factors
Measurement of NK cells subpopulations types in the maternal serum
• Serum factors
Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.

Locations
Country Name City State
Bulgaria Orthogyn Medical and Dental Center Sofia

Sponsors (1)
Lead Sponsor Collaborator
Orthogyn Medical Center, Bulgaria

Country where clinical trial is conducted

Bulgaria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurence of a spontaneous abortion Absent heart rate pulsations on an ultrasound scan Up to 24 weeks of gestation
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