Comprehensive Assessment of Risks for Miscarriage.
MIS-CARE
Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2020
CompletedFirst Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 26, 2023
October 1, 2023
3.4 years
June 25, 2020
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Occurence of a spontaneous abortion
Absent heart rate pulsations on an ultrasound scan
Up to 24 weeks of gestation
Study Arms (2)
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;
Interventions
CRL, HR, and other ultrasound measurements.
Measurement of NK cells subpopulations types in the maternal serum
Measuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances.
Eligibility Criteria
Pregnant women between 18 and 50 years of age.
You may qualify if:
- visualized fetal structures in utero \& heart pulsations until 8th week of gestation
- normal THS/T4 levels
- no uterine malformations
- BMI \< 27
- signed informed consent
You may not qualify if:
- fetal structures in utero \& heart pulsations not visualized until the 8th week of gestation
- elevated THS/T4 levels
- uterine malformations
- BMI \> 27
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthogyn Medical and Dental Center
Sofia, 1618, Bulgaria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petar N Ignatov, PhD
Orthogyn Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Petar Ignatov, MD, Ph.D.
Study Record Dates
First Submitted
June 25, 2020
First Posted
July 2, 2020
Study Start
June 20, 2020
Primary Completion
November 20, 2023
Study Completion
December 1, 2023
Last Updated
October 26, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share