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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breech Presentation

Detailed Description

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:

• Transabdominal ultrasound for evaluation of the following parameters: type of breech presentation, estimated fetal weight (according to Hadlock), maximum amniotic fluid flap, position of the placenta (anterior/posterior or fundic), angle between the fetal spine at the cervical level and the fetal occiput (occipital-spine angle).
• Transperineal ultrasound for evaluation of the following parameters: Breech Progression Angle (BPA), Subpubic Arch (SPA).

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD; Phone Number: 0512144412; Email: aly.youssef@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD; Phone Number: 0512144412; Email: aly.youssef@aosp.bo.it
  • Bologna, Italy, 40133
    • Recruiting
    • Ospedale Maggiore Carlo Alberto Pizzardi
    • Contact: Maria Segata, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with a single full-term pregnancy (37-42 gestational weeks) with a fetus in breech presentation

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the ultrasound performed before the version for external maneuvers of breech fetus

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Breech fetus
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Breech Presentation
• Other Study ID Numbers: ECV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No