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RecruitingNCT03827226BREXITUpdated Feb 6, 2024

Breech External Cephalic Version Intervention Trial

An observational study in Breech Presentation, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Charite University, Berlin, Germany · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breech Presentation

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03

In context

Breech Presentation

41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.

This study's planned enrollment of 200 is above the median of 135 across 10 observational studies indexed under Breech Presentation.

Browse Breech Presentation studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Browse Charite University, Berlin, Germany studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

All patients presenting with breech presentation to the antenatal clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presence of the written consent of the patients.
  • The patients must be over 18 years old .
  • No limit in the ability to consent.

Exclusion criteria

Exclusion criteria:

  • Age under 18
  • Limited ability to consent
  • Placenta previa
  • Fetal abnormalities
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Success rate of external cephalic version

    Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants,

    Time frame: 4 hours after external cephalic version

Secondary outcomes

  1. Sonographic Fetal Parameters: Head Circumference

    Measurements in mm

    Time frame: 30 Minutes before external cephalic version

  2. Sonographic Fetal Parameters: Abdominal Circumference

    Measurements in mm

    Time frame: 30 Minutes before external cephalic version

  3. Sonographic Fetal Parameters: Femur length

    Measurements in mm

    Time frame: 30 Minutes before external cephalic version

  4. Sonographic Fetal Parameters: Amniotic Fluid

    Measurements in mm

    Time frame: 30 Minutes before external cephalic version

  5. Fetal Doppler Indices middle cerebral

    Index Measurements/Ratios

    Time frame: 30 Minutes before external cephalic version

  6. Fetal Doppler Indices Umbilical Pulsatility Index

    Index Measurements/Ratios

    Time frame: 30 Minutes before external cephalic version

  7. Fetal Doppler Indices Umbilical Resistance Index

    Index Measurements/Ratios

    Time frame: 30 Minutes after external cephalic version

  8. Maternal Doppler Indices Uterine artery Right

    Index Measurements/Ratios

    Time frame: 30 Minutes before external cephalic version

  9. Maternal Doppler Indices Uterine artery Left

    Index Measurements/Ratios

    Time frame: 30 Minutes after external cephalic version

  10. Bladder volume

    Volume measurement

    Time frame: 30 Minutes before external cephalic version

  11. Distance Symphysis to Breech

    mm

    Time frame: 30 Minutes before external cephalic version

  12. 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)

    Time frame: 60 minutes before external cephalic version

  13. 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)

    Time frame: 120 Minutes after external cephalic version

  14. Fetal reflexes

    Percentage

    Time frame: 30 Minutes before external cephalic version

  15. Mode of delivery

    Type of delivery Vaginal or Caesarean

    Time frame: 6 weeks after delivery

  16. Incidence of fetal extended legs

    Numerical percentage

    Time frame: 30 Minutes before external cephalic version

  17. Incidence of bleeding

    Numerical percentage

    Time frame: 30 minutes after external cephalic version

  18. Incidence of ruptured membranes

    Numerical percentage

    Time frame: 30 minutes after external cephalic version

  19. Incidence of pathological Cardiotocogram

    Numerical percentage

    Time frame: 30 minutes after external cephalic version

  20. Incidence of emergency delivery

    Numerical percentage

    Time frame: 30 minutes after external cephalic version

  21. Pain scores

    Numerical score. Pain scale Linkert score. (0-10 with 10 being extremely painful)

    Time frame: 30 minutes after external cephalic version

  22. Incidence of tocolysis

    Numerical percentage

    Time frame: 30 minutes after external cephalic version

  23. Incidence of umbilical cord looping

    Numerical percentage

    Time frame: 30 Minutes before external cephalic version

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 10796122 ↗
  • American 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 26942387 ↗
  • External 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 28299867 ↗
  • Schauer 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2019 (actual). Primary completion is estimated for Jan 2025, 70 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2019
First posted
Feb 1, 2019
StartActual
Feb 5, 2019
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jun 1, 2025
Last update
Feb 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03827226
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Larry Hinkson (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Feb 1, 2019
Start date
Feb 5, 2019
Primary completion
Jan 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Feb 6, 2024

Study contacts

Larry Hinkson, FRCOG
Contact
Larry.Hinkson@charite.de
0049 (0)30450564015
Larry Hinkson, FRCOG
principal investigator · Consultant in Obstetrics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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