Clinical trial NCT06593795: Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Official title: Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breech Fetal Presentation
Breech Presentation of Fetus with Successful Version
Vaginal Delivery
Cesarean Section
Keywords: breech
external cephalic version
ultrasound
c-section
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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 \&lt;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 \&lt;4 cm)
* Uterine contractions
* Vaginal bleeding
* Premature rupture of membranes
* Nonreassuring fetal heart rate patterns before the procedure.

Primary outcomes:
measure: To evaluate ECV success rate.
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: silvio tartaglia, MD
role: STUDY_DIRECTOR
References: