NCT06593795

Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation

Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate possible predictors for the successful od external cephalic version (ECV), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. Before the procedure, a detailed ultrasound scan will be performed to measure several parameters. After the procedure we will collect data about the duration, outcome and eventual complications of ECV.

Detailed description

Pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ECV after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. The following anonymous data will be recorded: * Demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), BMI); * Parity * Gestational Age (weeks + days) Before ECV attempt, the following evaluations will be performed: * Vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating) * Fetal transvaginal ultrasound reporting: * biometry (BPD, HC, AC, FL, EFW); * Occiput position (right, left); * Back position (anterior, posterior, right, left); * Breech variant (footling, frank, complete); * Fetal leg posture (extended, flexed) * Placental localization; * Amniotic Fluid Index (AFI); * Fore-bag of amniotic fluid; * Eventual presence of nuchal cords; * Fetal head ballottement (yes, no); * Occiput-spine angle (see Figure 1) Then, all the participants will undergo a transabdominal ultrasound-guided ECV in a semi-sitting position by the same expert operator (B.C.). After the procedure, the following data will be collected: * Success (yes, no) * Duration of the procedure (min); * Direction of fetal flip in case of success (frontside flip, backside flip) * Pain perception in Numerical Rating Scale (NRS) (1-10); * Reason for terminating the procedure (success, failure, pain, uterine contractions, non-reassuring fetal conditions)

Conditions

• Breech Fetal Presentation
• Breech Presentation of Fetus with Successful Version
• Vaginal Delivery
• Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	ultrasound	before ECV procedure, an ultrasound will be performed to evaluate * fetal biometry (BPD, HC, AC, FL, EFW); * Occiput position (right, left); * Back position (anterior, posterior, right, left); * Breech variant (footling, frank, complete); * Fetal leg posture (extended, flexed) * Placental localization; * Amniotic Fluid Index (AFI); * Fore-bag of amniotic fluid; * Eventual presence of nuchal cords; * Fetal head ballottement (yes, no); * Occiput-spine angle These parameters will be compared to find predictive factors for successful ECV

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-09-19
• Last updated: 2024-09-19