Breech Presentation of Fetus With Successful VersionNCT04585256
Trendelenburg Positioning and External Cephalic Version Outcome
A study testing Trendelenburg positioning in people with Breech Presentation of Fetus With Successful Version, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breech Presentation of Fetus With Successful Version
- What is being tested?
- Trendelenburg positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to 31 Dec 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women interested in having external cephalic version at a gestational age of 37+0/7 or more.
Who cannot join
- Age 18 and under.
- Women with a body mass index 35 or higher.
- Women with a previous cesarean section.
- Women with premature rupture of membranes.
- Women with vaginal bleeding.
- Women with a previously failed external cephalic version.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Roy Lauterbach, MD, 0529432416, r_lauterbach@rambam.health.gov.il
About this study
Official title: The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.
Read the detailed description
This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.
The women that are eligible for participation will receive a thorough explanation and will sign informed consent.
- Being tested
- Trendelenburg positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positioningOther
Women positioned in the trendelenburg position prior to external cephalic version
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg | Active comparator | Women positioned in the trendelenburg position during external cephalic version. Receives: Other: Trendelenburg positioning |
| Control | No intervention | Women positioned on their back during external cephalic version. |
What is being measured
The primary outcome is the main question the study is designed to answer.
External cephalic version success
The rate of successful external cephalic version
Measured: Up to 10 minutes from the beginning of external cephalic version.
Secondary outcomes (4)
Pain
Visual analog scale scoring from 0-10 during and following the procedure.
Measured: Up to 2 hours from the beginning of external cephalic version.
Placental abruption
Rate of clinical placental abruption
Measured: Up to 1 week from the beginning of external cephalic version.
Vaginal delivery
Rate of vaginal deliveries
Measured: Up to 4 weeks from the beginning of external cephalic version.
Cesarean delivery
Rate of cesarean deliveries
Measured: Up to 4 weeks from the beginning of external cephalic version.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech Presentation of Fetus With Successful VersionStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585256
- Sponsor's protocol ID
- 0145-20-RMB
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
- ClinicalTrials.gov ID
- NCT04585256
- Acronym / sponsor ID
- 0145-20-RMB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Oct 2020 (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.
Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.
Detailed description
This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.
The women that are eligible for participation will receive a thorough explanation and will sign informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg | Active comparator | Other: Trendelenburg positioningWomen positioned in the trendelenburg position during external cephalic version. |
| Control | No intervention | –Women positioned on their back during external cephalic version. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women interested in having external cephalic version at a gestational age of 37+0/7 or more.
Key exclusion criteria (6 listed)
- Age 18 and under.
- Women with a body mass index 35 or higher.
- Women with a previous cesarean section.
- Women with premature rupture of membranes.
- Women with vaginal bleeding.
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 |
|---|---|---|
| Trendelenburg positioningWomen positioned in the trendelenburg position prior to external cephalic version | Other | Trendelenburg |
Primary outcome
External cephalic version success
Time frame: Up to 10 minutes from the beginning of external cephalic version.
The rate of successful external cephalic version
4 secondary outcomes
Pain
Time frame: Up to 2 hours from the beginning of external cephalic version.
Placental abruption
Time frame: Up to 1 week from the beginning of external cephalic version.
Vaginal delivery
Time frame: Up to 4 weeks from the beginning of external cephalic version.
Cesarean delivery
Time frame: Up to 4 weeks from the beginning of external cephalic version.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Breech Presentation of Fetus With Successful Version
Not yet recruitingObservational study
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version
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.
Roy Lauterbach, MD principal investigator
Rambam healthcare campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg positioning in people with Breech Presentation of Fetus With Successful Version, run by Rambam Health Care Campus 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 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy Lauterbach, MD (+972-52-9432416, r_lauterbach@rmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External cephalic version success (time frame: Up to 10 minutes from the beginning of external cephalic version.). 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 25 Jan 2023.