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Recruiting Observational

The Role of Ultrasonography in Labor in Predicting the Outcomes of Childbirth

NCT06806904 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-08-31
Last updated
2025-02-04

Condition(s) studied

Ultrasound in Labor

Study summary

Ultrasound in the delivery room represents a useful diagnostic tool and is used for the assessment of fetal presentation, fetal malpresentation/malposition, and prior to any operative delivery. Transperineal ultrasonography, performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora, has proven useful in providing information on the progression of the presented fetal part in the birth canal and in predicting birth outcomes. Many studies have shown a correlation between the above ultrasound indices and birth outcomes. These ultrasound indices are therefore used in clinical practice to assess the progression of the presented fetal part in the birth canal and the presence of fetal malpresentation/malposition. Despite this, to date, few studies have evaluated the correlation between dynamic changes in these ultrasound parameters between rest and maximal maternal pushing during the second stage of labor and birth outcomes.

Knowing before delivery which parameters are suggestive of possible dystocia would allow the clinician to adopt therapeutic strategies aimed at resolving them and thus increase the rate of spontaneous vaginal deliveries.

The investigators want to evaluate the role of an ultrasound parameter obtained by transabdominal ultrasound in the second stage of labor, the occiput-column angle, in predicting spontaneous delivery vaginally in fetuses with transverse occiput

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
44 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged \>= 18 years * Single pregnancy at term (37-42 gestational weeks) * Fetus in cephalic presentation and in expulsive period (complete cervical dilatation and premature sensation) * Acquisition of informed consent form Exclusion Criteria: * Placenta previa * Uterine malformations * Previous uterine surgery * Cardiotocographic tracing (CTG) abnormalities * Any contraindication to vaginal delivery

Primary outcome measure(s)

  • Measurement of Angle of Progression (AoP) — At the time of delivery: at rest and during maternal pushing
    Angle of progression (AoP): the angle between the longitudinal axis of the pubic symphysis and a straight line starting from the lower edge of the symphysis and passing tangentially to the most distal part of the fetal head
  • Measurement of Anteroposterior Pelvic Hiatus Diameter (APD) — At the time of delivery: at rest and during maternal pushing
    Anteroposterior pelvic hiatus diameter (APD): distance between the posteroinferior margin of the pubic symphysis and the anterior margin of the pubo-rectal muscle
  • Measurement of Head-Sympanic Distance (HSD) — At the time of delivery: at rest and during maternal pushing
    Head-symphysis distance (HSD): distance between the lower edge of the pubic symphysis and the nearest point of the fetal scalp along the infrapubic line
  • Measurement of Head-Perineum Distance (HPD) — At the time of delivery: at rest and during maternal pushing
    Head-Perineum Distance (HPD): distance between the perineum and the nearest point of the fetal scalp

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna 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 NCT06806904 on ClinicalTrials.gov ↗ ← All trials in Italy