Comprehensive Assessment of Risks for Miscarriage. (NCT04456660) | Clinical Trial Compass
UnknownNot Applicable
Comprehensive Assessment of Risks for Miscarriage.
Bulgaria200 participantsStarted 2020-06-20
Plain-language summary
This study aims to determine the role of serum biomarkers and placental bloodflow in the comprehensive evaluation of the risk for spontaneous abortion
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on assessing risks for miscarriage rather than testing a treatment, what would my actual participation involve — would I be providing data, samples, or just being monitored, and how much time would that require?
2Given that the recruitment status for this trial is listed as unknown, can you find out whether it is still actively enrolling patients or if it has been paused or closed?
3Because this trial is measuring the occurrence of miscarriage rather than trying to prevent one, is there any direct medical benefit to me as a participant, or would I mainly be contributing to research that helps future patients?
4If I have already experienced a spontaneous abortion or am considered at higher risk, would joining this kind of observational study conflict with or delay any standard diagnostic workup or treatment options you would recommend for me right now?
5What specific risk factors is this study trying to identify, and could participating help us better understand my own personal risk profile for miscarriage going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.