Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT06593795
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)
Study:
NCT06593795
Study Brief:
Protocol Section:
NCT06593795