Delivery Outcomes by AIDA (Artificial Intelligence Dystocia Algorithm) Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorCentro di Ricerca Clinica Salentino

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

pregnants in labor, at first pregnancy

gestational age ≥37 weeks of gestation

Disqualifiers

Patients who are candidates for cesarean section.

Patients in premature labor.

Patients who do not agree to participate in 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

Trial population

All healthy pregnants, at first pregnancy, in spontaneous or induced labor will be enrolled for the study, in order to better understand the outcomes of labor, monitored by intrapartum ultrasound parameters of labor assessed by AIDA method. The study will be conducted as observational study including pregnants in labor. In the collecting center, one person will be in charge for data collection and filling the SPSS database. As the study is observational and all the procedures will be conducted according to the local practice, all patients will sign an informed consent. Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • AIDA Analysis

    Device

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Labor1 intervention

Trial outcomes

Primary outcomes

1

Labor outcomes

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

Time frame
1 year

Secondary outcomes

1

Neonatal outcomes

The results of this study will show whether ultrasound parameters of dystocic labor assessed by AIDA method has a significant association with neonatal complications.

Time frame
1 year

Other outcomes

1

Fetal outcomes

The results of this study will show whether ultrasound parameters of dystocic labor assessed by AIDA method has a significant association with low fifth-minute Apgar score.

Time frame
1 year
2

Perinatal outcomes

The results of this study will show whether ultrasound parameters of dystocic labor assessed by AIDA method has a significant association with perinatal complications.

Time frame
1 year
3

NICU (Neonatal Intensive Care Unit) admittance outcomes

The results of this study will show whether ultrasound parameters of dystocic labor assessed by AIDA method has a significant association with NICU (Neonatal Intensive Care Unit) admittance.

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.