Comprehensive Assessment of Risks for Miscarriage.

NCT ID: NCT04456660

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-20

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spontaneous Abortion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Monitoring of pregnancy, including data on:

* maternal age and other demographic characteristics;
* ultrasound measurement of fetal heart rate (FHR) and crown-rump length (CRL)

No interventions assigned to this group

sFlt-1, Doppler and NK cells types group

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;

Markers of ultrasound

Intervention Type DIAGNOSTIC_TEST

CRL, HR, and other ultrasound measurements.

Immunologic factors

Intervention Type DIAGNOSTIC_TEST

Measurement of NK cells subpopulations types in the maternal serum

Serum factors

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Markers of ultrasound

CRL, HR, and other ultrasound measurements.

Intervention Type DIAGNOSTIC_TEST

Immunologic factors

Measurement of NK cells subpopulations types in the maternal serum

Intervention Type DIAGNOSTIC_TEST

Serum factors

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orthogyn Medical Center, Bulgaria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Petar Ignatov

Assist. Prof. Petar Ignatov, MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Petar N Ignatov, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthogyn Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orthogyn Medical and Dental Center

Sofia, , Bulgaria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Petar N Ignatov, PhD

Role: CONTACT

0035988896318 ext. 00359

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Petar D Ignatov, PhD

Role: primary

00359888963189 ext. 00359

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MIS-CARE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.