An interventional study of Video in Breech Presentation, sponsored by Meir Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Treatment
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.
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).
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 200 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
this group do not watch an informative video before recruitment
All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
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.
Time frame: 4 years
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.
Time frame: 4 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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