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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Spontaneous Abortion

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