An Informative Video Before Planned External Cephalic Version

Breech Presentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187948
• Other study ID #: 0214-22
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2023
• Source: Meir Medical Center
• Contact: Hila Shalev, Dr
• Phone: 972508807380
• Email: hila6070[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women between ages 18-45

• with a singleton gestation

• at gestational week of 36 weeks 0 days until 38 weeks 0 days

• who admitted labor word for external cephalic version .

Exclusion Criteria:

• Women who had a past cesarean section

• Women with oligohydramnios (Amniotic fluid index < 5 cm)

• Women who had a past external cephalic version

• Women with a failed external cephalic version in current pregnancy

• Women who take medication for depression/anxiety disorders

• Women with a complicated pregnancy including fetal anomalies, polyhydramnios…

Related Conditions & MeSH terms

• Breech Presentation

Intervention

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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	higher success rates.	Comparing the percentage of successful External Cephalic Version (ECV) procedures between patients who watched an informative video about the procedure and those who did not receive this intervention.	4 years
Secondary	impact of watching an informative video before external cephalic version on maternal anxiety levels	Assessing anxiety levels using the State-Trait Anxiety Inventory, administered at two time frames - before the External Cephalic Version (ECV) and an hour after - to determine if women who watch an informative video about the procedure experience lower anxiety compared to those who do not.	4 years