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NCT06816563: ECV
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
trial in Breech Presentation in 200 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 11 January 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Italy |
Conditions studied
- Breech Presentation — all drugs for Breech Presentation →
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →
Who can join
Adults 18 to 45, female only, with Breech Presentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06816563
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Related trials
Other recruiting trials for Breech Presentation
Currently open trials in the same condition.
- NCT06187948 — An Informative Video Before Planned External Cephalic Version · NA · recruiting
- NCT04579835 — Twin A Breech External Cephalic Version Intervention Trial (TWEXIT) · recruiting
Other IRCCS Azienda Ospedaliero-Universitaria di Bologna trials
Trials by the same sponsor.
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- NCT07483853 — Reliability and Validation of the WB-MRI Radiological Score in CRMO · recruiting
- NCT07479121 — These Studies Assess Surgeons' Physical and Ergonomic Workloads. Study 1 Compares Laparoscopic vs. Hugo RAS Robotic Appr · NA · not yet recruiting
- NCT07471009 — Development of Patient Derived Xenografts (PDXs) and Analysis of Tyrosine Kinase Receptor Expression in Patients With Sq · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06816563 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 10 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06816563.
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