An Informative Video Before Planned External Cephalic Version

Not Applicable

Recruiting

• Conditions: Breech Presentation
• Interventions: Other: Video

• Registration Number: NCT06187948
• Lead Sponsor: Meir Medical Center

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).

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study Start: 2023-12-26
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 .

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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...

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. group that watches an informative video	Video	All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

Primary Outcome Measures

Name	Time	Method
higher success rates.	4 years	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.

Secondary Outcome Measures

Name	Time	Method
impact of watching an informative video before external cephalic version on maternal anxiety levels	4 years	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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel