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

NCT ID: NCT06593795

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group ECV

Pregnant women with a fetus in breech presentation at term of pregnancy undergoing an external cephalic version (ECV) maneuver. This procedure is aimed to induce fetal cephalic position allowing vaginal delivery instead of cesarean section

ultrasound

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥18 y.o.;
• Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;
• Singleton;
• At term (≥ 37 weeks);
• Breech presentation;
• No previous uterine scars or other indications for elective C-section;
• Signed written informed consent to study participation.

Exclusion Criteria

• Age <18 y.o.;
• Preterm gestational age;
• Multiple pregnancies;
• Indications for elective cesarean section;
• Incomplete obstetrical data;
• Refusal to provide informed consent.
• Desire to an elective C-Section
• Controindications for ECV or vaginal delivery (placental abruption, placenta previa, uterine malformations)
• Reduction of amniotic fluid (AFI <4 cm)
• Uterine contractions
• Vaginal bleeding
• Premature rupture of membranes
• Nonreassuring fetal heart rate patterns before the procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Carducci Brigida

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

silvio tartaglia, MD

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Central Contacts

Silvio Tartaglia, MD

Role: CONTACT

silvio.tartaglia@guest.policlinicogemelli.it

(555) 555-1234

Sascia Moresi, MD

Role: CONTACT

sascia.moresi@policlinicogemelli.it

Other Identifiers

6366

Identifier Type: -

Identifier Source: org_study_id