Breech PresentationTWEXITNCT04579835
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
An observational study of Breech Presentation and Twin; Complicating Pregnancy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation, Twin; Complicating Pregnancy
- What is being tested?
- External Cephalic Version
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 28 Sep 2020to 28 Sep 2026
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presenting with Twin A breech presentation to the antenatal clinic
Who may be able to join
- Presence of the written consent of the patients.
- The patients must be over 18 years old .
- No limit in the ability to consent.
Who cannot join
- Age under 18
- Limited ability to consent
- Placenta previa
- Fetal abnormalities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Hospital
Mitte, 10117
Larry Hinkson, FRCOG
About this study
Official title: Twin A Breech External Cephalic Version Intervention Trial
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.
Read the detailed description
The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.
- Conditions
- Breech Presentation, Twin; Complicating Pregnancy
- Being tested
- External Cephalic Version
- Medical subject headings
- Breech Presentation, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Cephalic VersionOther
External Cephalic Version Twin A
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of external cephalic version Twin A
Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants
Measured: 4 hours after external cephalic version
Secondary outcomes (10)
Fetal weight
Measurement in grams
Measured: 30 Minutes before external cephalic version
Fetal Doppler Umbilical Pulsatility Index
Index mesurent /Ratio
Measured: 30 Minutes before external cephalic version
Fetal Doppler Umbilical Resistance Index
Index mesurent /Ratio
Measured: 30 Minutes before external cephalic version
Incidence of pathological cardiotocogramm
Numerical percentage
Measured: 60 Minutes after external cephalic version
Incidence of emergency delivery
Numerical percentage
Measured: 60 Minutes after external cephalic version
Incidence of bleeding
Numerical percentage
Measured: 60 Minutes after external cephalic version
Incidence of contractions
Numerical percentage
Measured: 60 Minutes after external cephalic version
Incidence of rupture of membranes
Numerical percentage
Measured: 60 Minutes after external cephalic version
Pain scores
Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)
Measured: 60 Minutes after external cephalic version
Mode of Delivery
Type of delivery (vaginal or caesarean)
Measured: 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Sep 2020
- Primary completion28 Sep 2025 (estimated)
- Study completion28 Sep 2026 (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.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Hinkson, Charite University, Berlin, Germany
- Investigators
- Larry Hinkson, FRCOG, Principal investigator, Charité University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579835
- Sponsor's protocol ID
- EA2/116/20
- Acronym
- TWEXIT
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin A Breech External Cephalic Version Intervention Trial
- ClinicalTrials.gov ID
- NCT04579835
- Acronym / sponsor ID
- TWEXIT / EA2/116/20
- Conditions
- Breech Presentation, Twin; Complicating Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 8 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.
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.
Detailed description
The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with Twin A breech presentation to the antenatal clinic
Key inclusion criteria (3 listed)
- Presence of the written consent of the patients.
- The patients must be over 18 years old .
- No limit in the ability to consent.
Key exclusion criteria (4 listed)
- Age under 18
- Limited ability to consent
- Placenta previa
- Fetal abnormalities
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 Twin A | Other | – |
Primary outcome
Success rate of external cephalic version Twin A
Time frame: 4 hours after external cephalic version
Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants
10 secondary outcomes
Fetal weight
Time frame: 30 Minutes before external cephalic version
Fetal Doppler Umbilical Pulsatility Index
Time frame: 30 Minutes before external cephalic version
Fetal Doppler Umbilical Resistance Index
Time frame: 30 Minutes before external cephalic version
Incidence of pathological cardiotocogramm
Time frame: 60 Minutes after external cephalic version
Incidence of emergency delivery
Time frame: 60 Minutes after external cephalic version
Incidence of bleeding
Time frame: 60 Minutes after external cephalic version
Incidence of contractions
Time frame: 60 Minutes after external cephalic version
Incidence of rupture of membranes
Time frame: 60 Minutes after external cephalic version
Pain scores
Time frame: 60 Minutes after external cephalic version
Mode of Delivery
Time frame: 6 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
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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. This study is not recruiting at the moment.
Larry Hinkson, FRCOG principal investigator
Charité University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breech Presentation and Twin; Complicating Pregnancy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 4 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 6 Feb 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 Germany. 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 Larry Hinkson, FRCOG (004930450664710, Larry.Hinkson@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of external cephalic version Twin A (time frame: 4 hours after 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 6 Feb 2024.