Analyzing labor outcomes using an artificial intelligence algorithm
Study of Delivery Outcomes After AIDA (Artificial Intelligence Dystocia Algorithm) Analysis
This study is testing an AI tool to see if it can help understand and improve outcomes for women during both normal and complicated labor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Centro di Ricerca Clinica Salentino Research network |
| Locations | 2 sites (Scorrano, Lecce and 1 other locations) |
| Trial ID | NCT06664112 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of both normal and complicated labor by utilizing the Artificial Intelligence Dystocia Algorithm (AIDA). It focuses on assessing intrapartum ultrasound parameters such as the Angle of Progression, Asynclitism Degree, Fetal Head-Symphysis Distance, and Midline Angle. The study will also investigate neonatal outcomes, including Apgar scores, for both eutocic and dystocic labor cases. By analyzing these parameters, the study seeks to improve understanding and management of labor complications.
Who should consider this trial
Good fit: Ideal candidates include first-time pregnant women at or beyond 37 weeks of gestation who are candidates for spontaneous or induced labor.
Not a fit: Patients who are multiparas, candidates for cesarean section, or experiencing premature labor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance labor management and reduce the need for surgical deliveries by providing better insights into fetal positioning.
How similar studies have performed: While the use of AI in labor management is emerging, this specific application of the AIDA method is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients in pregnancy, nulliparae, candidates for spontaneous or induced labor, monitored by intrapartum ultrasound, collecting the ultrasound parameters of the labor progress. 1. pregnants in labor, at first pregnancy 2. gestational age ≥37 weeks of gestation Exclusion Criteria: Multiparas who are candidates for cesarean section, premature labor and patients who do not agree to participate in the study (missing data relevant for the study). Exclusion criteria encompassed: breech, transverse, or oblique presentations; twin pregnancies; abnormal placental implantation; HELLP syndrome; coagulation disorders; uterine hyperstimulation (often referred to as "terrified uterus"); non-reassuring fetal heart rate; thick meconium; and cephalopelvic disproportion. 1. Patients who are candidates for cesarean section. 2. Patients in premature labor. 3. Patients who do not agree to participate in the study. 4. Exclusion criteria encompassed: breech, transverse, or oblique presentations; twin pregnancies; abnormal placental implantation; HELLP syndrome; coagulation disorders; uterine hyperstimulation (often referred to as "terrified uterus"); non-reassuring fetal heart rate; thick meconium; and cephalopelvic disproportion 5. Missing data relevant for the study.
Where this trial is running
Scorrano, Lecce and 1 other locations
- Ospedale Veris delli Ponti — Scorrano, Lecce, Italy (Recruiting)
- Andrea Tinelli — Lecce, Le, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Tinelli, MD
- Email: andreatinelli@gmail.com
- Phone: +393392074078
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.