Comprehensive Assessment of Risks for Miscarriage.

Orthogyn Medical Center, Bulgaria200 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Spontaneous Abortion

Interventions

Markers of ultrasoundDIAGNOSTIC_TEST

CRL, HR, and other ultrasound measurements.

Immunologic factorsDIAGNOSTIC_TEST

Measurement of NK cells subpopulations types in the maternal serum

Serum factorsDIAGNOSTIC_TEST

Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Orthogyn Medical and Dental Center

Sofia, Bulgaria

RECRUITING

Outcomes

Primary Outcomes

Occurence of a spontaneous abortion

Absent heart rate pulsations on an ultrasound scan

Time frame: Up to 24 weeks of gestation

Central Contacts

Petar N Ignatov, PhD

CONTACT

0035988896318 ignatov@orthogyn.com

Data from ClinicalTrials.gov

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