Breech Presentation; Before LaborECVBLADDERNCT04118465
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
A study testing external cephalic version in people with Breech Presentation; Before Labor, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. 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; Before Labor
- What is being tested?
- external cephalic version
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2002to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- non-cephalic presentation,
- singleton pregnancy,
- term gestation,
- No previous attempt at ECV in this pregnancy,
- signed informed consent.
Who cannot join
- Any contraindication for vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
Read the detailed description
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
- Conditions
- Breech Presentation; Before Labor
- Being tested
- external cephalic version
- Keywords
- breech; ECV; version
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external cephalic versionProcedure or surgery
external cephalic version
| Study group | Role | What they receive |
|---|---|---|
| ECV with Full urinary bladder | Active comparator | ECV with Full urinary bladder Receives: Procedure: external cephalic version |
| ECV with empty urinary bladder | Active comparator | ECV with empty urinary bladder Receives: Procedure: external cephalic version |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECV success rate
ECV success rate
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startJan 2002
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breech Presentation; Before LaborStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezra Yosi, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118465
- Sponsor's protocol ID
- ECVBLAD-HMO-CTIL
- Acronym
- ECVBLADDER
- Status last verified
- Feb 2021
- First submitted
- 5 Oct 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kabiri D, Haj Yahya R, Yahalomi S, Ezra Y. Impact of full vs empty urinary bladder on external cephalic version success: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100991. doi: 10.1016/j.ajogmf.2023.100991. Epub 2023 Apr 30.
PubMed 38236701
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
- ClinicalTrials.gov ID
- NCT04118465
- Acronym / sponsor ID
- ECVBLADDER / ECVBLAD-HMO-CTIL
- Conditions
- Breech Presentation; Before Labor
- Keywords
- breech; ECV; version
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2002 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Oct 2019 (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 comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
Detailed description
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECV with Full urinary bladder | Active comparator | Procedure: external cephalic versionECV with Full urinary bladder |
| ECV with empty urinary bladder | Active comparator | Procedure: external cephalic versionECV with empty urinary bladder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-cephalic presentation,
- singleton pregnancy,
- term gestation,
- No previous attempt at ECV in this pregnancy,
- signed informed consent.
Key exclusion criteria (1 listed)
- Any contraindication for vaginal delivery
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 |
|---|---|---|
| external cephalic versionexternal cephalic version | Procedure or surgery | ECV with Full urinary bladder, ECV with empty urinary bladder |
Primary outcome
ECV success rate
Time frame: immediate
ECV success rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 38236701Kabiri D, Haj Yahya R, Yahalomi S, Ezra Y. Impact of full vs empty urinary bladder on external cephalic version success: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100991. doi: 10.1016/j.ajogmf.2023.100991. Epub 2023 Apr 30.
- Individual participant dataSharing planned: Yes
Related trials for Breech Presentation; Before Labor
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
Recruiting
An Informative Video Before Planned External Cephalic Version
Breech Presentation
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external cephalic version in people with Breech Presentation; Before Labor, run by Hadassah Medical Organization 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECV success rate (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118465, which also lists 1 linked publication.
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 10 Feb 2021.