Spontaneous AbortionMIS-CARENCT04456660
Comprehensive Assessment of Risks for Miscarriage.
An observational study of Spontaneous Abortion, run by Orthogyn Medical Center, Bulgaria at 1 site in Bulgaria.
Trial summary
This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Abortion
- What is being tested?
- Markers of ultrasound, Immunologic factors and Serum factors
- How many people
- 200 participants
- Where
- 1 siteBulgaria
- Study dates
- 20 Jun 2020to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between 18 and 50 years of age.
Who may be able to join
- visualized fetal structures in utero \& heart pulsations until 8th week of gestation
- normal THS/T4 levels
- no uterine malformations
- BMI < 27
- signed informed consent
Who cannot join
- fetal structures in utero \& heart pulsations not visualized until the 8th week of gestation
- elevated THS/T4 levels
- uterine malformations
- BMI > 27
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Orthogyn Medical and Dental Center
Sofia, 1618
Petar D Ignatov, PhD, 00359888963189 ext. 00359, ignatov@orthogyn.com
About this study
Official title: 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
Read the 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.
- Conditions
- Spontaneous Abortion
- Being tested
- Markers of ultrasound, Immunologic factors, Serum factors
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Diagnostic Test: Markers of ultrasound; Diagnostic Test: Immunologic factors; Diagnostic Test: Serum factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of a spontaneous abortion
Absent heart rate pulsations on an ultrasound scan
Measured: Up to 24 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start20 Jun 2020
- Primary completion20 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthogyn Medical Center, Bulgaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Ignatov, Orthogyn Medical Center, Bulgaria
- Investigators
- Petar N Ignatov, PhD, Principal investigator, Orthogyn Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456660
- Sponsor's protocol ID
- MIS-CARE
- Acronym
- MIS-CARE
- Status last verified
- Oct 2023
- First submitted
- 25 Jun 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.
- ClinicalTrials.gov ID
- NCT04456660
- Acronym / sponsor ID
- MIS-CARE / MIS-CARE
- Conditions
- Spontaneous Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Orthogyn Medical Center, BulgariaUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: Markers of ultrasound, Diagnostic Test: Immunologic factors, Diagnostic Test: Serum factorsMonitoring 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; |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between 18 and 50 years of age.
Key inclusion criteria (5 listed)
- visualized fetal structures in utero \& heart pulsations until 8th week of gestation
- normal THS/T4 levels
- no uterine malformations
- BMI < 27
- signed informed consent
Key exclusion criteria (4 listed)
- fetal structures in utero \& heart pulsations not visualized until the 8th week of gestation
- elevated THS/T4 levels
- uterine malformations
- BMI > 27
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markers of ultrasoundCRL, HR, and other ultrasound measurements. | Diagnostic test | sFlt-1, Doppler and NK cells types group |
| Immunologic factorsMeasurement of NK cells subpopulations types in the maternal serum | Diagnostic test | sFlt-1, Doppler and NK cells types group |
| Serum factorsMeasuring the maternal serum concentration of sFlt-1, PLGF, glycodelin-A, and other substances. | Diagnostic test | sFlt-1, Doppler and NK cells types group |
Primary outcome
Occurence of a spontaneous abortion
Time frame: Up to 24 weeks of gestation
Absent heart rate pulsations on an ultrasound scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Spontaneous Abortion
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petar N Ignatov, PhD principal investigator
Orthogyn Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Abortion, run by Orthogyn Medical Center, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petar N Ignatov, PhD (0035988896318 ext. 00359, ignatov@orthogyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of a spontaneous abortion (time frame: Up to 24 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.