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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
AIDA Analysis
DeviceThe 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
Trial outcomes
Primary outcomes
Labor outcomes
To investigate outcomes of labor, in correlation to intrapartum ultrasound monitoring analyzed by AIDA method.
Secondary outcomes
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.
Other outcomes
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.
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.
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.
Sponsors and contacts
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