NCT06187948

An Informative Video Before Planned External Cephalic Version

An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Breech Presentation

Interventions

Type	Name	Description
OTHER	Video	All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

Timeline

• Start date: 2023-12-26
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Israel