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

October 23, 2023 updated by: Petar Ignatov, Orthogyn Medical Center, Bulgaria

Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Recruiting
        • Orthogyn Medical and Dental Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Pregnant women between 18 and 50 years of age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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;
Diagnostic test: Markers of ultrasound
CRL, HR, and other ultrasound measurements.
Diagnostic test: Immunologic factors
Measurement of NK cells subpopulations types in the maternal serum
Diagnostic test: Serum factors
Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of a spontaneous abortion
Time Frame: Up to 24 weeks of gestation
Absent heart rate pulsations on an ultrasound scan
Up to 24 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthogyn Medical Center, Bulgaria

Investigators

  • Principal Investigator: Petar N Ignatov, PhD, Orthogyn Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2020

Primary Completion (Estimated)

November 20, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIS-CARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Abortion

Clinical Trials on Markers of ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe