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RecruitingNCT04579835TWEXITUpdated Feb 6, 2024

Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

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

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breech Presentation
  • Twin; Complicating Pregnancy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All patients presenting with Twin A breech presentation to the antenatal clinic

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
04

Study design

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

Interventions

  • OtherExternal Cephalic Version

    External Cephalic Version Twin A

05

What researchers measure

Primary outcomes

  1. Success rate of external cephalic version Twin A

    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. Fetal weight

    Measurement in grams

    Time frame: 30 Minutes before external cephalic version

  2. Fetal Doppler Umbilical Pulsatility Index

    Index mesurent /Ratio

    Time frame: 30 Minutes before external cephalic version

  3. Fetal Doppler Umbilical Resistance Index

    Index mesurent /Ratio

    Time frame: 30 Minutes before external cephalic version

  4. Incidence of pathological cardiotocogramm

    Numerical percentage

    Time frame: 60 Minutes after external cephalic version

  5. Incidence of emergency delivery

    Numerical percentage

    Time frame: 60 Minutes after external cephalic version

  6. Incidence of bleeding

    Numerical percentage

    Time frame: 60 Minutes after external cephalic version

  7. Incidence of contractions

    Numerical percentage

    Time frame: 60 Minutes after external cephalic version

  8. Incidence of rupture of membranes

    Numerical percentage

    Time frame: 60 Minutes after external cephalic version

  9. Pain scores

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

    Time frame: 60 Minutes after external cephalic version

  10. Mode of Delivery

    Type of delivery (vaginal or caesarean)

    Time frame: 6 weeks after delivery

06

Study locations

1 of 1 sites recruiting
  • Charité University Hospital
    Berlin-Mitte, 10117, Germany
    • Larry Hinkson, FRCOG · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04579835
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Larry Hinkson (Lead Consultant in Obstetrics, Deputy Director, Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 8, 2020
Start date
Sep 28, 2020
Primary completion
Sep 28, 2025 (estimated)
Completion
Sep 28, 2026 (estimated)
Last update
Feb 6, 2024

Study contacts

Larry Hinkson, FRCOG
Contact
Larry.Hinkson@charite.de
004930450664710
Larry Hinkson, FRCOG
principal investigator · Charité University Hospital

Oversight

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

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