Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593795
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Sponsor:
None
Organization:
None
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:
No
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 ie 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 BC 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 ie 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 BC 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None