Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

NCT06664112 · tracked via the Priya Life Science Italy tracker

Sponsor

Centro di Ricerca Clinica Salentino

Phase

Observational

Started

2024-09-30

Last updated

2024-12-03

Condition(s) studied

Delivery ComplicationDelivery ProblemDelivery; InjuryDelivery; Injury, MaternalDelivery;Breech;StillbirthDelivery Problem for Fetus

Investigational drug(s) / intervention(s)

AIDA Analysis

AIDA Analysis: The women will be followed until and after the birth, under intrapartum ultrasound monitoring, with all clinical, ultrasonographic and obstetric parameters, analyzed by AIDA method.

Study summary

Aims:

Primary aim is to investigate outcomes of eutocic labor, evaluating intrapartum ultrasound parameters by AIDA method: Angle of progression (AoP), Asynclitism degree (AD), fetal head-symphysis distance (HSD), and midline angle (MLA).

Secondary aim is to investigate outcomes of dystocic labor, evaluating intrapartum ultrasound parameters by AIDA method: Angle of progression (AoP), Asynclitism degree (AD), fetal head-symphysis distance (HSD), and midline angle (MLA).

Tertiary aim is to investigate of neonatal outcomes of eutocic labor: Apgar scores at 1 min, Apgar scores at 5 min.

Quaternary aim is to investigate of neonatal outcomes of dystocic labor: Apgar scores at 1 min, Apgar scores at 5 min.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

45 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Labor outcomes — 1 year
To investigate outcomes of labor, in correlation to intrapartum ultrasound monitoring analyzed by AIDA method.

Trial sites (2)

Facility	City	Region	Status
Ospedale Veris delli Ponti	Scorrano	Lecce	Recruiting
Andrea Tinelli	Lecce	Le	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664112 on ClinicalTrials.gov ↗ ← All trials in Italy