Assessing risks for miscarriage using biomarkers and ultrasound
Markers of Ultrasound, Immunologic & Serum Factors in the Comprehensive Analysis of Risks for Early Pregnancy Loss.
Orthogyn Medical Center, Bulgaria · NCT04456660
This study is trying to see if checking certain blood markers and ultrasound images can help predict the risk of miscarriage for pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Orthogyn Medical Center, Bulgaria (other) |
| Locations | 1 site (Sofia) |
| Trial ID | NCT04456660 on ClinicalTrials.gov |
What this trial studies
This study evaluates the risk factors associated with spontaneous abortion by analyzing serum biomarkers, immunologic factors, and ultrasound parameters. It aims to determine the added value of these combined assessments in predicting miscarriage risk. Participants will undergo evaluations to visualize fetal structures and heart pulsations, alongside testing for specific serum and immunologic markers. The study is observational and does not involve any experimental treatments.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals who can visualize fetal structures and heart pulsations by the 8th week of gestation and meet specific health criteria.
Not a fit: Patients who do not have visualized fetal structures or heart pulsations by the 8th week, or who have elevated thyroid hormone levels or uterine malformations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment for miscarriage, allowing for better management and support for expectant mothers.
How similar studies have performed: While the approach of using biomarkers and ultrasound for miscarriage risk assessment is not widely established, similar studies have shown promise in identifying risk factors for pregnancy complications.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sofia
- Orthogyn Medical and Dental Center — Sofia, Bulgaria (RECRUITING)
Study contacts
- Principal investigator: Petar N Ignatov, PhD — Orthogyn Medical Center
- Study coordinator: Petar N Ignatov, PhD
- Email: ignatov@orthogyn.com
- Phone: 0035988896318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spontaneous Abortion