Comprehensive Assessment of Risks for Miscarriage. (MIS-CARE)

Orthogyn Medical Center, Bulgaria

Status: Enrolling

Conditions: Spontaneous Abortion

Treatments: Diagnostic Test: Immunologic factors; Diagnostic Test: Serum factors; Diagnostic Test: Markers of ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04456660

MIS-CARE

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Control group

Description:

Monitoring of pregnancy, including data on: * maternal age and other demographic characteristics; * ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL)

sFlt-1, Doppler and NK cells types group

Description:

Monitoring of pregnancy, including data on: * maternal age and other demographic characteristics; * ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL), uterine arteries PI, and other parameters; * measurement of serum sFlt-1, PLGF, and glycodelin-A levels, as well as other parameters; * measurement of CD16+, CD56+, and other subpopulations of NK cells;

Treatment:

Diagnostic Test: Serum factors

Diagnostic Test: Immunologic factors

Diagnostic Test: Markers of ultrasound