Assessing signal loss in maternal heart rate monitoring during labor
Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording
This study looks at how often and why heart rate monitors lose signal during labor to see how it affects babies and the need for extra medical help.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06906744 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the frequency and causes of signal loss in cardiotocography (CTG) recordings, which are crucial for monitoring fetal well-being during labor. It aims to gather updated data on the impact of signal loss on neonatal morbidity and unnecessary obstetric interventions, addressing a gap in knowledge that has persisted for over a decade. The study will involve adult females who have undergone CTG in the labor and delivery room at a specific hospital during a defined time period.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females aged 18 and older who are in labor and have a gestational age greater than 36 weeks.
Not a fit: Patients who have not undergone cardiotocography or those with a gestational age of less than 36 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that enhance fetal well-being and reduce unnecessary medical interventions.
How similar studies have performed: While there is limited recent data on this specific issue, previous studies have highlighted the importance of accurate CTG monitoring, suggesting that addressing signal loss could be a significant advancement.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult female (≥ 18 years old) * Patient treated at a hospital between February 1, 2024 and February 28, 2024 * Having undergone cardiotocography in the labor and delivery room * Gestational age at delivery \>36 weeks Exclusion Criteria: * Patient who has expressed opposition to the use of medical record data * Patient without CTG * Gestational age at delivery \<36 weeks
Where this trial is running
Strasbourg
- Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Georges-Emmanuel ROTH, Midwife
- Email: georges-emmanuel.roth@chru-strasbourg.fr
- Phone: 33.3.69.55.35.46
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.