Comprehensive Assessment of Risks for Miscarriage.

Recruiting

• Conditions: Spontaneous Abortion
• Interventions: Diagnostic Test: Markers of ultrasound; Diagnostic Test: Immunologic factors; Diagnostic Test: Serum factors

• Registration Number: NCT04456660
• Lead Sponsor: Orthogyn Medical Center, Bulgaria

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-06-20
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-26
• Primary Completion: 2023-11-20
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sFlt-1, Doppler and NK cells types group	Immunologic factors	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;
sFlt-1, Doppler and NK cells types group	Serum factors	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;
sFlt-1, Doppler and NK cells types group	Markers of ultrasound	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;

Primary Outcome Measures

Name	Time	Method
Occurence of a spontaneous abortion	Up to 24 weeks of gestation	Absent heart rate pulsations on an ultrasound scan

Trial Locations

Locations (1)

Orthogyn Medical and Dental Center; 🇧🇬 Sofia, Bulgaria