An observational study in Breech Presentation, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 2 sites in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
Patients will be recruited before starting the cephalic version for external maneuvers. An ultrasound evaluation will be performed for each patient before the external maneuver version of breech fetus; specifically, the following will be performed:
If the external maneuver version is successful, an additional transperineal ultrasound will be performed for evaluation of Angle of Progression (AoP).
After delivery, data will be recorded regarding mode of delivery, indication for operative delivery (in case of cesarean section or obstetric suction), neonatal arterial and venous pH, possible admission to the NICU. These data will be collected by consulting the medical records of recruited patients. The population will be recruited as part of the normal care pathway.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 200 is above the median of 135 across 10 observational studies indexed under Breech Presentation.
Browse Breech Presentation studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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Women with a single full-term pregnancy (37-42 gestational weeks) with a fetus in breech presentation
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of new ultrasound indexes (Breech Progression Angle, BPA)
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
Time frame: During the ultrasound performed before the version for external maneuvers of breech fetus
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