Measuring heart function in pregnant women using non-invasive techniques
Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques: Comparison Between USCOM, ICON and Trans Thoracic Echography
This study is testing two new non-invasive heart monitoring techniques in pregnant women to see how well they measure heart function compared to the standard ultrasound method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneve) |
| Trial ID | NCT06114147 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of new non-invasive techniques, the Index of Contractility Monitor (ICON) and the Ultra Sonic Cardiac Output Monitor (USCOM), in measuring cardiac output, systolic ejection volume, and vascular filling in pregnant women. The study will assess these measurements against the gold standard of trans-thoracic ultrasound during the first and third trimesters of pregnancy. Additionally, it will evaluate patient comfort, examination time, and examiner satisfaction with each technique. Participants will be enrolled from the first trimester and monitored until delivery, with specific consultations scheduled for measurements.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals over 16 years old attending prenatal consultations at the Geneva University Hospitals.
Not a fit: Patients with preexisting or congenital heart conditions or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer and more comfortable methods for monitoring cardiac function in pregnant women.
How similar studies have performed: While the specific combination of techniques in this study may be novel, similar non-invasive approaches have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any pregnant person over 16 years old followed at the prenatal consultation of the maternity ward of the Geneva University Hospitals. Exclusion Criteria: * Drug or alcohol abuse, * Miscarriage or intra uterine demise before the first exam. * Inability to follow the procedures of the investigation, e.g. due to psychological disorders, dementia, etc. of the subject, * Inability to give an informed consent. * preexisting or congenital cardiopathy * Structural abnormalities of hearth or valves diagnosed in the first Trans Thoracic Echocardiography screening
Where this trial is running
Geneve
- Hopitaux Universitaires de Geneve — Geneve, Switzerland (Recruiting)
Study contacts
- Principal investigator: Bénédicte LE TINIER, MD — Hopitaux universitaires de Geneve
- Study coordinator: bénédicte LE TINIER, MD
- Email: benedictine.letinier@hcuge.ch
- Phone: 0041795530127
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.