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Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

Twin A Breech External Cephalic Version Intervention Trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04579835
Acronym
TWEXIT
Enrollment
45
Registered
2020-10-08
Start date
2020-09-28
Completion date
2026-09-28
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation, Twin; Complicating Pregnancy

Brief summary

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.

Interventions

External Cephalic Version Twin A

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

* Age under 18 * Limited ability to consent * Placenta previa * Fetal abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Success rate of external cephalic version Twin A4 hours after external cephalic versionMean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants

Secondary

MeasureTime frameDescription
Fetal Doppler Umbilical Pulsatility Index30 Minutes before external cephalic versionIndex mesurent /Ratio
Fetal Doppler Umbilical Resistance Index30 Minutes before external cephalic versionIndex mesurent /Ratio
Incidence of pathological cardiotocogramm60 Minutes after external cephalic versionNumerical percentage
Incidence of emergency delivery60 Minutes after external cephalic versionNumerical percentage
Fetal weight30 Minutes before external cephalic versionMeasurement in grams
Incidence of contractions60 Minutes after external cephalic versionNumerical percentage
Incidence of rupture of membranes60 Minutes after external cephalic versionNumerical percentage
Pain scores60 Minutes after external cephalic versionNumerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful)
Mode of Delivery6 weeks after deliveryType of delivery (vaginal or caesarean)
Incidence of bleeding60 Minutes after external cephalic versionNumerical percentage

Countries

Germany

Contacts

Primary ContactLarry Hinkson, FRCOG
Larry.Hinkson@charite.de004930450664710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026