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Search / Trial NCT06664112

Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

Launched by CENTRO DI RICERCA CLINICA SALENTINO · Oct 28, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Dystocia Dystocic Labor Asynclitism Intrapartum Ultrasound Labor Outcomes Delivery Outcomes Operative Delivery Complications

ClinConnect Summary

This clinical trial, called AIDA (Artificial Intelligence Dystocia Algorithm) Analysis, is focused on understanding how certain ultrasound measurements during labor can help improve delivery outcomes. It aims to study two types of labor: normal (eutocic) and complicated (dystocic). The researchers will measure things like the position of the baby's head and how well the labor is progressing to see how these factors affect the health of both the mother and baby during delivery. They will also look at the baby's condition right after birth, using scores that assess how well the baby is doing at one and five minutes after delivery.

To participate in this trial, women who are in their first pregnancy and at least 37 weeks along may be eligible, as long as they are planning for a vaginal delivery and agree to have their labor monitored with ultrasound. However, those with certain complications, such as multiple pregnancies or those needing a cesarean section, will not be included. If you decide to join, you can expect to have your labor closely monitored with ultrasound, and your contributions may help improve future care for other mothers and babies facing similar situations.

Gender

FEMALE

Eligibility 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.

About Centro Di Ricerca Clinica Salentino

Centro di Ricerca Clinica Salentino is a leading clinical research organization dedicated to advancing medical science through innovative clinical trials. With a focus on patient-centered research, the center collaborates with healthcare professionals and industry partners to facilitate the development of new therapies and medical interventions. Committed to maintaining the highest ethical standards and regulatory compliance, the center emphasizes rigorous scientific methodology and comprehensive data analysis, ensuring the integrity and reliability of its findings. By fostering a collaborative environment, Centro di Ricerca Clinica Salentino aims to contribute significantly to the improvement of healthcare outcomes both locally and globally.

Locations

Scorrano, Lecce, Italy

Lecce, Le, Italy

Patients applied

0 patients applied

Trial Officials

Andrea Tinelli, MD

Study Director

Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported