Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-20 @ 12:01 AM
Study NCT ID:
NCT06593795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVERSO
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)
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: