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Vaginal Birth After Caesarean Section – Effect on Maternal Psychosocial Function

This study has been completed.
Study NCT00294411.   Last updated on February 21, 2006.   Information provided by Chinese University of Hong Kong

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Descriptive Information Fields
Brief Title  Vaginal Birth After Caesarean Section – Effect on Maternal Psychosocial Function
Official Title 
Brief Summary

The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. What we do know is that antenatal depression and unplanned caesarean section are major risk factors for postpartum depression, which in turn is the major cause of maternal mortality in many developed countries including Hong Kong. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section. The Hypothesis is that there is a significant difference in psychosocial function between these 2 groups of patients.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  General Health Questionnaire (GHQ)
Secondary Outcome Measure  State-Trait Anxiety Inventory
Beck Depression Inventory
Edinburgh Postnatal Depression Scale
Client Satisfaction Questionnaire
MRC Social Performance Schedule
WHO Quality of Life questionnaire
Condition  Vaginal Birth After Cesarean
Intervention  Procedure: elective cesarean section
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  December 2003
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • women who agree for vaginal birth after prior cesarean section and who had no previous history of vaginal delivery

Exclusion Criteria:

  • Inability or unwillingness to give informed consent. Multiple pregnancy, more than one previous caesarean section, and a previous classical caesarean section, presence of other contra-indications to vaginal birth
Gender Female
Ages
Accepts Healthy Volunteers
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00294411
Organization ID 4423/03M
Secondary IDs ††
Study Sponsor  Chinese University of Hong Kong
Collaborators ††
Investigators 
Principal Investigator:     Tze Kin LAU, MD     Chinese University of Hong Kong    
Information Provided By Chinese University of Hong Kong
Verification Date February 2006
First Received Date  February 21, 2006
Last Updated Date February 21, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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