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

NCT06816563 | Recruiting

• 1 other identifier: ECV
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breech Presentation

Keywords

Breech fetus

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, Bologna, 40133, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

CONTACT

0512144412; aly.youssef@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 10, 2025
• Study Start: January 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-11

Locations

IT (2)