Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187948
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-05-02
Brief Title:
An Informative Video Before Planned External Cephalic Version
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success - a Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success
Detailed Description:
Women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the Emergency Room by offering every woman that is scheduled to undergo an external cephalic version to participate Women who agree to participate are asked to sign an inform consent and are randomized to intervention group and control group In the Emergency Room sonographic data is collected including amniotic fluid index engaged presenting part sonographic and clinical estimation of fetal weight place of the placenta and various angles between the fetus and the bladder These data are collected for the study All participants in the intervention group watches an informative video on recruitment This video describes in detail the expected external cephalic version process
Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score Attached
Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score Attached
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None