An Informative Video Before Planned External Cephalic Version

Clalit Health Services

Status: Enrolling

Conditions: Breech Presentation

Treatments: Other: Video

Study type: Interventional

Funder types: Other

Identifiers

NCT06187948

0214-22

Details and patient eligibility

About

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

Full 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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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...

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1. group that watches an informative video

Experimental group

Description:

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

Treatment:

Other: Video

2. group that does not watch an informative video

No Intervention group

Description:

this group do not watch an informative video before recruitment