Actively Recruiting
Twin A Breech External Cephalic Version Intervention Trial
Led by Charite University, Berlin, Germany · Updated on 2024-02-06
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of external cephalic version (ECV) for managing Twin A breech presentation in twin pregnancies. The study seeks to determine the success rate of this procedure at an obstetric clinic and to identify new sonographic criteria that may predict successful ECV attempts, which have not been explored before. Participants will undergo the external cephalic version procedure targeting Twin A in the pregnancy. The study will monitor and assess various factors such as fetal weight, Doppler indices, and maternal and fetal outcomes shortly before and after the procedure. Follow-up will continue with evaluations including delivery mode six weeks after birth. During the study, participants will be assessed through ultrasound measurements, cardiotocogram monitoring, and pain scoring at specific intervals before and after the ECV procedure. Researchers will track outcomes such as emergency delivery, bleeding, contractions, and rupture of membranes. The primary outcome is the success rate of the ECV measured four hours after the procedure, with additional follow-up up to six weeks postpartum.
CONDITIONS
Brief Title
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of written consent from the patient
- Patients must be over 18 years old
- No limit in the ability to consent
You will not qualify if you...
- Age under 18
- Limited ability to consent
- Placenta previa
- Fetal abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo External Cephalic Version for Twin A as part of the study procedures.
1 visit (in-person)
Duration - Up to 6 weeks after delivery
Participants are monitored for safety and outcomes up to 6 weeks after delivery.
1 visit 6 weeks after delivery and assessments immediately before and after the procedure
Trial Site Locations
Total: 1 location
1
Charité University Hospital
Mitte, Germany, 10117
Actively Recruiting
Research Team
L
Larry Hinkson, FRCOG
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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