Informative video before external cephalic version for breech presentation
An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial
NA · Meir Medical Center · NCT06187948
This study tests if watching an informative video can help reduce anxiety and improve the success of a procedure to turn breech babies for women preparing for that treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Meir Medical Center (other) |
| Locations | 1 site (Kfar Saba) |
| Trial ID | NCT06187948 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of an informative video on maternal anxiety and the success rate of external cephalic version (ECV) in women with breech presentations. Women scheduled for ECV are recruited and randomized into two groups: one that views the informative video and a control group that does not. The study measures anxiety levels before and after the procedure using the State-Trait Anxiety Inventory. Sonographic data is also collected to assess various factors related to the pregnancy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a singleton pregnancy at 36 to 38 weeks gestation who are scheduled for an external cephalic version.
Not a fit: Patients who have had a previous cesarean section, complicated pregnancies, or those taking medication for anxiety or depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce maternal anxiety and improve the success rates of external cephalic version.
How similar studies have performed: Other studies have shown that educational interventions can reduce anxiety and improve outcomes in similar medical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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…
Where this trial is running
Kfar Saba
- Meir Medical Center — Kfar Saba, Israel (RECRUITING)
Study contacts
- Study coordinator: Hila Shalev, Dr
- Email: hila6070@gmail.com
- Phone: 972508807380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breech Presentation, breech presentation, external cephalic version, maternal anxiety, informative video