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NCT00517140 Clinical Trial

Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Pregnancy Clinical Trial

Official title:
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517140
Other study ID # CRE-2003.118
Secondary ID HARECCTR0500014
Status Completed
Phase N/A
First received August 15, 2007
Last updated June 14, 2011
Start date September 2003
Est. completion date April 2007

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 262
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

All women who:

- Have one prior caesarean section

- No prior vaginal delivery and

- Agree for either vaginal delivery or elective caesarean section

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Repeat Caesaen section

• vaginal delivery

Locations
Country Name City State
China Department of Obstetrics and Gynaecology, Prince of Wales Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary pscyiatric morbidity after delivery
Secondary Psychosocial function 3 and 6 months after delivery
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