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Clinical Trials in Italy / NCT06816563
Recruiting Observational

Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle

NCT06816563 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2021-01-11
Last updated
2025-02-10

Condition(s) studied

Breech Presentation

Study summary

Breech presentation complicates about 3-4% of single pregnancies at term. Although vaginal delivery is also possible in breech presentations, this is associated with an increased risk of fetal morbidity and mortality. The cephalic version for external maneuvers is an obstetric procedure that allows conversion of an abnormal presentation/situation (breech or transverse) to a cephalic presentation by applying pressure to the maternal abdomen. Over the years, many authors have analyzed numerous factors that might be associated with an increased likelihood of successful maneuvering. Over time, transperineal ultrasonography has proven to be a valid, objective, and highly reproducible tool for the assessment of fetal head progression during delivery in conjunction with examination. The Angle of Progression (AoP) is the angle between the line passing through the longitudinal axis of the pubic symphysis and the line passing through the inferior border of the pubic symphysis and tangent to the fetal skull. AoP is an accurate and reproducible parameter for the assessment of fetal head descent during labor, with a strong correlation with the mode of delivery. The investigators are not aware of any studies that have established the role of transperineal ultrasound in assessing podietal engagement and its role in predicting the success of the cephalic version maneuver, an aspect the investigators want to explore with this study.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Women \>18 years of age with a single pregnancy at term (37-42 gestational weeks) with a fetus in breech presentation * Acquisition of Informed Consent Form Exclusion Criteria: * Oligohydramnios: maximum flap \< 2cm * Placenta previa * Uterine malformations * Regular uterine dynamics * Metrorrhagia * Contraindications to vaginal delivery * Premature rupture of membranes * Nonreassuring cardiotocographic tracing * Previous uterine surgery

Primary outcome measure(s)

  • Evaluation of new ultrasound indexes (Breech Progression Angle, BPA) — During the ultrasound performed before the version for external maneuvers of breech fetus
    Evaluation using transperineal ultrasonography, the role of a new ultrasound index (Breech Progression Angle, BPA) in predicting the success of external maneuver version of breech fetus

Trial sites (2)

FacilityCityRegionStatus
Ospedale Maggiore Carlo Alberto Pizzardi Bologna Bologna Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting

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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 NCT06816563 on ClinicalTrials.gov ↗ ← All trials in Italy