Actively Recruiting
Age: 20Years - 45Years
FEMALE
Healthy Volunteers
ID06664112
Study of Delivery Outcomes After AIDA (Artificial Intelligence Dystocia Algorithm) Analysis
Led by Centro di Ricerca Clinica Salentino · Updated on 2024-12-03
1000
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating delivery outcomes using the Artificial Intelligence Dystocia Algorithm (AIDA) method, which analyzes intrapartum ultrasound parameters such as Angle of Progression, Asynclitism degree, fetal head-symphysis distance, and midline angle. The study focuses on both eutocic (normal) and dystocic (difficult) labor, aiming to assess labor progress and predict outcomes including neonatal Apgar scores at 1 and 5 minutes. This approach addresses challenges in fetal head positioning that affect labor progression and delivery decisions. Participants will be monitored during labor using intrapartum ultrasound with clinical and obstetric parameters analyzed by the AIDA method. The AIDA system classifies labor into five categories based on these geometric parameters, helping to predict whether cesarean delivery will be necessary. This observational study follows women through labor and after birth, using artificial intelligence combined with physician decision support to evaluate labor progress and outcomes. During the study, women will undergo ultrasound monitoring and have their labor progress tracked by the AIDA analysis. Researchers will measure labor outcomes and neonatal health indicators over one year. Data collected includes ultrasound parameters, clinical assessments, and delivery results. The study aims to improve understanding of labor complications and support clinical decisions by providing detailed evaluations of fetal positioning and labor progression.
CONDITIONS
Brief Title
Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis
Who Can Participate
Age: 20Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant women at their first pregnancy
- Candidates for spontaneous or induced labor
- At or beyond 37 weeks of gestation
- Monitored by intrapartum ultrasound collecting labor progress parameters
You will not qualify if you...
- Multiparas who are candidates for cesarean section
- Patients in premature labor
- Patients who do not agree to participate in the study
- Breech, transverse, or oblique fetal presentations
- Twin pregnancies
- Abnormal placental implantation
- HELLP syndrome
- Coagulation disorders
- Uterine hyperstimulation ("terrified uterus")
- Non-reassuring fetal heart rate
- Thick meconium
- Cephalopelvic disproportion
- Missing data relevant for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - From labor onset until birth
Participants are followed during labor and delivery with intrapartum ultrasound monitoring. Clinical, ultrasonographic, and obstetric parameters are collected and analyzed using the AIDA method to evaluate labor progress and predict delivery outcomes.
Continuous monitoring during labor
Long-term Monitoring
Duration - Up to 1 year after birth
Participants are monitored for labor and neonatal outcomes up to 1 year after delivery to assess the implications of AIDA analysis on birth results and neonatal health.
Follow-up visits as needed up to 1 year
Trial Site Locations
Total: 2 locations
1
Ospedale Veris delli Ponti
Scorrano, Lecce, Italy, 73020
Actively Recruiting
2
Andrea Tinelli
Lecce, Le, Italy, 73100
Actively Recruiting
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Research Team
A
Andrea Tinelli, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The Pathophysiology of Labor Dystocia: Theme with Variations.
Katherine Kissler, K Joseph Hurt
https://pubmed.ncbi.nlm.nih.gov/35817950Labor Dystocia in Nulliparous Women.
Nicholas M LeFevre, Ellisa Krumm, William Jacob Cobb
https://pubmed.ncbi.nlm.nih.gov/33448772Asynclitism: a literature review of an often forgotten clinical condition.
Antonio Malvasi, Antonio Barbera, Giovanni Di Vagno...
https://pubmed.ncbi.nlm.nih.gov/25283847Sagittal suture overlap in cephalopelvic disproportion: blinded and non-participant assessment.
Eckhart J Buchmann, Elena Libhaber
https://pubmed.ncbi.nlm.nih.gov/18696276Asynclitism in the second stage of labor: prevalence, associations, and outcome.
Catherine M W Hung, Viola Y T Chan, Tullio Ghi...
https://pubmed.ncbi.nlm.nih.gov/34217855Asynclitism and Its Ultrasonographic Rediscovery in Labor Room to Date: A Systematic Review.
Antonio Malvasi, Marina Vinciguerra, Bruno Lamanna...
https://pubmed.ncbi.nlm.nih.gov/36553005Intrapartum ultrasound and the choice between assisted vaginal and cesarean delivery.
Viola Ying Tze Chan, Wai Lam Lau
https://pubmed.ncbi.nlm.nih.gov/34216834Occiput posterior position diagnosis: vaginal examination or intrapartum sonography? A clinical review.
A Malvasi, A Tinelli, A Barbera...
https://pubmed.ncbi.nlm.nih.gov/23865738The use of intrapartum ultrasound to diagnose malpositions and cephalic malpresentations.
Federica Bellussi, Tullio Ghi, Aly Youssef...
https://pubmed.ncbi.nlm.nih.gov/28743440