Breech PresentationNCT06187948
An Informative Video Before Planned External Cephalic Version
A study testing Video in people with Breech Presentation, run by Meir Medical Center at 1 site in Israel.
Trial summary
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Dec 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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…
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Hila Shalev, MD
About this study
Official title: An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.
Read the 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).
- Conditions
- Breech Presentation
- Being tested
- Video
- Keywords
- breech presentation, external cephalic version, maternal anxiety, informative video
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
| Study group | Role | What they receive |
|---|---|---|
| 1. group that watches an informative video | Experimental | All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process. Receives: Other: Video |
| 2. group that does not watch an informative video | No intervention | this group do not watch an informative video before recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start26 Dec 2023 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorit Ravid, Dr, Study director, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187948
- Sponsor's protocol ID
- 0214-22
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06187948
- Acronym / sponsor ID
- 0214-22
- Conditions
- Breech Presentation
- Keywords
- breech presentation, external cephalic version, maternal anxiety, informative video
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 26 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. group that watches an informative video | Experimental | Other: VideoAll participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process. |
| 2. group that does not watch an informative video | No intervention | –this group do not watch an informative video before recruitment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoAll participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process. | Other | 1. group that watches an informative video |
Primary outcome
higher success rates.
Time frame: 4 years
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.
1 secondary outcome
impact of watching an informative video before external cephalic version on maternal anxiety levels
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorit Ravid, Dr study director
Meir Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with Breech Presentation, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Shalev, Dr (972508807380, hila6070@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
higher success rates. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.