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

NCT06593795 | Not Yet Recruiting

• 1 other identifier: 6366
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

breech; external cephalic version; ultrasound; c-section

Outcome Measures

Primary Outcomes (1)

• To evaluate ECV success rate.

  to evaluate clinical and ultrasound parameters possibly predictive of the success of ECV. This will allow the creation of a predictive model for adequate counseling for the women undergoing the procedure for the cephalic version of fetuses in breech presentation at term of pregnancy

  during the procedure

Study Arms (1)

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

Procedure: ultrasound

Interventions

ultrasound 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

Group ECV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will consecutively enroll all pregnant women at the term of gestation with a fetal breech presentation undergoing ECV attempt after counseling at Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome, satisfying the inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Breech Presentation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• silvio tartaglia, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  STUDY DIRECTOR

Central Study Contacts

Silvio Tartaglia, MD

CONTACT

(555) 555-1234; silvio.tartaglia@guest.policlinicogemelli.it

Sascia Moresi, MD

CONTACT

sascia.moresi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share