Breech PresentationBREXITNCT03827226
Breech External Cephalic Version Intervention Trial
An observational study of Breech Presentation, 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 breech presentation in pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 5 Feb 2019to 1 Jun 2025
- 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
- Adult, Older adult
Study population: All patients presenting with 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: Breech External Cephalic Version Intervention Trial- A Prospective Study
A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.
Read the detailed description
The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.
- Conditions
- Breech Presentation
- Medical subject headings
- Breech Presentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of external cephalic version
Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,
Measured: 4 hours after external cephalic version
Secondary outcomes (23)
Sonographic Fetal Parameters: Head Circumference
Measurements in mm
Measured: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Abdominal Circumference
Measurements in mm
Measured: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Femur length
Measurements in mm
Measured: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Amniotic Fluid
Measurements in mm
Measured: 30 Minutes before external cephalic version
Fetal Doppler Indices middle cerebral
Index Measurements/Ratios
Measured: 30 Minutes before external cephalic version
Fetal Doppler Indices Umbilical Pulsatility Index
Index Measurements/Ratios
Measured: 30 Minutes before external cephalic version
Fetal Doppler Indices Umbilical Resistance Index
Index Measurements/Ratios
Measured: 30 Minutes after external cephalic version
Maternal Doppler Indices Uterine artery Right
Index Measurements/Ratios
Measured: 30 Minutes before external cephalic version
Maternal Doppler Indices Uterine artery Left
Index Measurements/Ratios
Measured: 30 Minutes after external cephalic version
Bladder volume
Volume measurement
Measured: 30 Minutes before external cephalic version
Distance Symphysis to Breech
mm
Measured: 30 Minutes before external cephalic version
Depression and Anxiety Stress scale score
A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)
Measured: 60 minutes before external cephalic version
Depression and Anxiety Stress scale score
A scale score with a range from 0 to 42 (0-10 is normal and 35-42 extremely severe)
Measured: 120 Minutes after external cephalic version
Fetal reflexes
Percentage
Measured: 30 Minutes before external cephalic version
Mode of delivery
Type of delivery Vaginal or Caesarean
Measured: 6 weeks after delivery
Incidence of fetal extended legs
Numerical percentage
Measured: 30 Minutes before external cephalic version
Incidence of bleeding
Numerical percentage
Measured: 30 minutes after external cephalic version
Incidence of ruptured membranes
Numerical percentage
Measured: 30 minutes after external cephalic version
Incidence of pathological Cardiotocogram
Numerical percentage
Measured: 30 minutes after external cephalic version
Incidence of emergency delivery
Numerical percentage
Measured: 30 minutes after external cephalic version
Pain scores
Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)
Measured: 30 minutes after external cephalic version
Incidence of tocolysis
Numerical percentage
Measured: 30 minutes after external cephalic version
Incidence of umbilical cord looping
Numerical percentage
Measured: 30 Minutes before 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 posted1 Feb 2019
- Study start5 Feb 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 200 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, Consultant in Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827226
- Sponsor's protocol ID
- EA2/241/18
- Acronym
- BREXIT
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.
PubMed 10796122American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312.
PubMed 26942387External Cephalic Version and Reducing the Incidence of Term Breech Presentation: Green-top Guideline No. 20a. BJOG. 2017 Jun;124(7):e178-e192. doi: 10.1111/1471-0528.14466. Epub 2017 Mar 16. No abstract available.
PubMed 28299867Schauer M, Latartara E, Alonso-Espias M, Rossetti E, Gebert P, Henrich W, Hinkson L. Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study. Arch Gynecol Obstet. 2023 Feb;307(2):409-419. doi: 10.1007/s00404-022-06509-0. Epub 2022 Mar 27.
PubMed 35344082
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
- Breech External Cephalic Version Intervention Trial- A Prospective Study
- ClinicalTrials.gov ID
- NCT03827226
- Acronym / sponsor ID
- BREXIT / EA2/241/18
- Conditions
- Breech Presentation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Feb 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 prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.
Detailed description
The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with 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.
Primary outcome
Success rate of external cephalic version
Time frame: 4 hours after external cephalic version
Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,
23 secondary outcomes
Sonographic Fetal Parameters: Head Circumference
Time frame: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Abdominal Circumference
Time frame: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Femur length
Time frame: 30 Minutes before external cephalic version
Sonographic Fetal Parameters: Amniotic Fluid
Time frame: 30 Minutes before external cephalic version
Fetal Doppler Indices middle cerebral
Time frame: 30 Minutes before external cephalic version
Fetal Doppler Indices Umbilical Pulsatility Index
Time frame: 30 Minutes before external cephalic version
Fetal Doppler Indices Umbilical Resistance Index
Time frame: 30 Minutes after external cephalic version
Maternal Doppler Indices Uterine artery Right
Time frame: 30 Minutes before external cephalic version
Maternal Doppler Indices Uterine artery Left
Time frame: 30 Minutes after external cephalic version
Bladder volume
Time frame: 30 Minutes before external cephalic version
Distance Symphysis to Breech
Time frame: 30 Minutes before external cephalic version
Depression and Anxiety Stress scale score
Time frame: 60 minutes before external cephalic version
Depression and Anxiety Stress scale score
Time frame: 120 Minutes after external cephalic version
Fetal reflexes
Time frame: 30 Minutes before external cephalic version
Mode of delivery
Time frame: 6 weeks after delivery
Incidence of fetal extended legs
Time frame: 30 Minutes before external cephalic version
Incidence of bleeding
Time frame: 30 minutes after external cephalic version
Incidence of ruptured membranes
Time frame: 30 minutes after external cephalic version
Incidence of pathological Cardiotocogram
Time frame: 30 minutes after external cephalic version
Incidence of emergency delivery
Time frame: 30 minutes after external cephalic version
Pain scores
Time frame: 30 minutes after external cephalic version
Incidence of tocolysis
Time frame: 30 minutes after external cephalic version
Incidence of umbilical cord looping
Time frame: 30 Minutes before 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 6 Feb 2024.
- Background: PubMed 10796122Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000083. doi: 10.1002/14651858.CD000083.
- Results publication: PubMed 26942387American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312.
- Results publication: PubMed 28299867External Cephalic Version and Reducing the Incidence of Term Breech Presentation: Green-top Guideline No. 20a. BJOG. 2017 Jun;124(7):e178-e192. doi: 10.1111/1471-0528.14466. Epub 2017 Mar 16. No abstract available.
- Derived from this study: PubMed 35344082Schauer M, Latartara E, Alonso-Espias M, Rossetti E, Gebert P, Henrich W, Hinkson L. Depression, anxiety and stress in women with breech pregnancy compared to women with cephalic presentation-a cross-sectional study. Arch Gynecol Obstet. 2023 Feb;307(2):409-419. doi: 10.1007/s00404-022-06509-0. Epub 2022 Mar 27.
- Individual participant dataSharing planned: No
Related trials for Breech Presentation
RecruitingObservational study
Clinical Validation of an Artificial Intelligence System for De-termining Fetal Lie and Position in 3rd Trimester
Pregnancy, Fetal Presentation
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
RecruitingObservational study
Discourse on the Mother's Decision Regarding the Mode of Delivery in Cases of Breech Presentation
Breech Presentation
RecruitingObservational study
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
Breech Presentation
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.
Larry Hinkson, FRCOG principal investigator
Consultant in Obstetrics
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, 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 (0049 (0)30450564015, 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 (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?
On the ClinicalTrials.gov record for NCT03827226, which also lists 4 linked publications.
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.