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Crossing international boundaries: implications for the Term Breech Trial Data Coordinating Centre
Sheila A Hewson1, Julie Weston, Mary E Hannah
1Maternal Infant and Reproductive Health Research Unit, The Centre for Research in Women's Health, University of Toronto, 790 Bay Street, 7th Floor, Toronto, Ontario, Canada. sheila.hewson@utoronto.ca
Controlled Clinical Trials
|February 20, 2002
Summary
The Term Breech Trial (TBT) compared planned cesarean birth versus planned vaginal birth for term breech presentation. International collaboration significantly impacted TBT
Area of Science:
- Obstetrics and Gynecology
- Perinatal Medicine
- Clinical Trial Management
Background:
- Term breech presentation poses delivery challenges.
- International randomized trials are crucial for evidence-based obstetric practice.
- The Term Breech Trial (TBT) addressed delivery mode for term breech infants.
Purpose of the Study:
- To describe the impact of international collaboration on data coordinating center activities for the Term Breech Trial (TBT).
- To outline challenges and strategies in managing a large, multicenter, international randomized trial.
- To highlight key operational aspects of multicenter trial coordination.
Main Methods:
- Multicenter, international randomized trial design.
- Comparison of planned cesarean section versus planned vaginal birth for term breech presentation.
- Detailed description of data coordinating center activities: center selection, ethics, data management, funding, and recruitment.
Main Results:
- The TBT involved 121 centers in 26 countries.
- 2088 women were recruited between January 1997 and April 2000.
- The paper focuses on the operational aspects of managing the trial's collaborative efforts.
Conclusions:
- Successful international collaboration is vital for large-scale clinical trials.
- Effective data coordinating center management is essential for trial integrity and success.
- Lessons learned from TBT collaboration can inform future multicenter obstetric research.