Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: External Cephalic Version.
- Who it may be relevant to
- Registry conditions: Breech Presentation, Twin; Complicating Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Twin A Breech External Cephalic Version Intervention Trial
Overview
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
- Other External Cephalic Version
External Cephalic Version Twin A
Primary outcome measures
- Success rate of external cephalic version Twin A [Time frame: 4 hours after external cephalic version]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité University Hospital — Mitte
Identifiers
NCT: NCT04579835 · EA2/116/20