Skip to content

An Informative Video Before Planned External Cephalic Version

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06187948
Enrollment
200
Registered
2024-01-03
Start date
2023-12-26
Completion date
2027-12-01
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation

Keywords

breech presentation, external cephalic version, maternal anxiety, informative video

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).

Interventions

OTHERVideo

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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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…

Design outcomes

Primary

MeasureTime frameDescription
higher success rates.4 yearsComparing 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

MeasureTime frameDescription
impact of watching an informative video before external cephalic version on maternal anxiety levels4 yearsAssessing 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.

Countries

Israel

Contacts

Primary ContactHila Shalev, Dr
hila6070@gmail.com972508807380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026