Actively Recruiting
An Informative Video Before Planned External Cephalic Version Does it Reduce Maternal Anxiety and Improve Chances of Success? A Randomized Control Trial
Led by Meir Medical Center · Updated on 2024-01-03
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on pregnant women with a breech presentation who are scheduled for an external cephalic version (ECV), a procedure to turn the baby to a head-down position before birth. The study aims to determine if watching an informative video before the planned ECV can reduce maternal anxiety and improve the chances of a successful version. The trial is randomized and sponsored by Meir Medical Center. Participants are divided into two groups: one group watches an informative video that explains the ECV process in detail, while the other group does not watch any video before the procedure. Sonographic data such as amniotic fluid index, fetal weight estimates, placenta location, and fetal position angles are collected in the Emergency Room. Anxiety levels are measured using the State-Trait Anxiety Inventory both before and an hour after the ECV, regardless of success. Women in the study will undergo the ECV procedure with clinical monitoring and data collection before and after the intervention. Researchers will assess the primary outcome of higher success rates of the ECV over four years and a secondary outcome measuring the impact of the video on maternal anxiety levels. Participation involves scheduled assessments and monitoring during the procedure, with follow-up for anxiety evaluation and success rates.
CONDITIONS
Brief Title
An Informative Video Before Planned External Cephalic Version
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women between ages 18-45
- Pregnant with a single baby (singleton gestation)
- Gestational age between 36 weeks 0 days and 38 weeks 0 days
- Scheduled for external cephalic version procedure
You will not qualify if you...
- History of cesarean section
- Oligohydramnios with amniotic fluid index less than 5 cm
- Previous external cephalic version
- Failed external cephalic version in current pregnancy
- Taking medication for depression or anxiety disorders
- Complicated pregnancy including fetal anomalies or polyhydramnios
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) in the Emergency Room
Duration - Day of the external cephalic version procedure
Participants are either shown an informative video describing the external cephalic version process or receive no video before undergoing the external cephalic version procedure. Anxiety levels are measured before and one hour after the procedure.
1 visit (in-person) including the procedure and assessments
Trial Site Locations
Total: 1 location
1
Meir Medical Center
Kfar Saba, Israel
Actively Recruiting
Research Team
H
Hila Shalev, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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