An Informative Video Before Planned External Cephalic Version
ConditionBreech Presentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMeir Medical Center
About this trial
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 .
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Video
Other interventionAll participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: 1. group that watches an informative videoExperimental treatment 1 intervention
Group B: 2. group that does not watch an informative videoNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 yearsSponsors and contacts
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Source ClinicalTrials.gov