Creating a model to predict fetal pH at birth using cardiotocography data
Development of a Predictive Model of Fetal PH At Birth from Novel Variables Derived from Cardiotocographic Tracing
This study is trying to create a tool that uses heart rate and contraction data during labor to better predict if a baby might have low oxygen levels at birth, helping to improve care for pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06720363 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a predictive model for fetal acidosis by analyzing cardiotocographic tracing data collected during labor. The study will focus on participants with single pregnancies undergoing spontaneous or induced delivery, utilizing continuous monitoring of fetal heart rate and maternal contractions. By extracting and processing this data, the researchers hope to identify new variables that can enhance the accuracy of fetal well-being assessments and reduce the risk of unnecessary obstetric interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 45 years with a single pregnancy who are undergoing continuous labor monitoring.
Not a fit: Patients with multiple pregnancies or those who do not meet the age and monitoring criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this model could lead to improved fetal monitoring and timely interventions during labor, ultimately enhancing neonatal outcomes.
How similar studies have performed: While there is limited data on predictive models specifically for fetal acidosis using cardiotocography, similar approaches in fetal monitoring have shown promise in improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age between 18 and 45 years; * Single pregnancy * Participants undergoing continuous monitoring of labor labor * Obtaining informed consent for study participation and processing of personal data Exclusion Criteria: * None
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Farina, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Antonio Farina, MD
- Email: antonio.farina@unibo.it
- Phone: 0512143110
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.