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NCT Number: NCT06187948

An Informative Video Before Planned External Cephalic Version

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center

Kfar Saba, Israel

Location status: Recruiting

Location contact

Hila Shalev, MD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…

Treatment and study plan

video

Other

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

Primary outcomes

  1. higher success rates.

    Time frame: 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 outcomes

  1. impact of watching an informative video before external cephalic version on maternal anxiety levels

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hila Shalev, Dr

CONTACT

[email protected]

972508807380

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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