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

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

Study Overview

• Status: Recruiting
• Conditions: Breech Presentation
• Intervention / Treatment: Other: Video

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hila Shalev, Dr; Phone Number: 972508807380; Email: hila6070@gmail.com

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Hila Shalev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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…

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. group that watches an informative video; All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.	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.
No Intervention: 2. group that does not watch an informative video; this group do not watch an informative video before recruitment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Study Director: Dorit Ravid, Dr, Meir Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: external cephalic version; breech presentation; maternal anxiety; informative video
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breech Presentation
• Other Study ID Numbers: 0214-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No