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Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Primary Purpose

Pregnancy, Cesarean Section, Uterine Rupture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repeat Caesaen section
vaginal delivery
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy women with a scarred uterus due to previous caesarean section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Female

Inclusion Criteria:

All women who:

  • Have one prior caesarean section
  • No prior vaginal delivery and
  • Agree for either vaginal delivery or elective caesarean section

Sites / Locations

  • Department of Obstetrics and Gynaecology, Prince of Wales Hospital

Outcomes

Primary Outcome Measures

pscyiatric morbidity

Secondary Outcome Measures

Psychosocial function

Full Information

First Posted
August 15, 2007
Last Updated
June 14, 2011
Sponsor
Hospital Authority, Hong Kong
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00517140
Brief Title
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
Official Title
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Chinese University of Hong Kong

4. Oversight

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Cesarean Section, Uterine Rupture
Keywords
Pregnancy women with a scarred uterus due to previous caesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Repeat Caesaen section
Intervention Type
Procedure
Intervention Name(s)
vaginal delivery
Primary Outcome Measure Information:
Title
pscyiatric morbidity
Time Frame
after delivery
Secondary Outcome Measure Information:
Title
Psychosocial function
Time Frame
3 and 6 months after delivery

10. Eligibility

Sex
Female
Eligibility Criteria
Inclusion Criteria: All women who: Have one prior caesarean section No prior vaginal delivery and Agree for either vaginal delivery or elective caesarean section
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tze Kin Lau, Prof
Organizational Affiliation
Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology, Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

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