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Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

This study has been completed.

Sponsors and Collaborators: Hospital Authority, Hong Kong
Chinese University of Hong Kong
Information provided by: Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT00517140
  Purpose

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.


Condition Intervention
Pregnancy
Cesarean Section
Uterine Rupture
Procedure: Repeat Caesaen section
Procedure: vaginal delivery

MedlinePlus related topics:   Cesarean Section   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • pscyiatric morbidity [ Time Frame: after delivery ]

Secondary Outcome Measures:
  • Psychosocial function [ Time Frame: 3 and 6 months after delivery ]

Enrollment:   262
Study Start Date:   September 2003
Study Completion Date:   April 2007

  Eligibility
Genders Eligible for Study:   Female

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517140

Locations
China
Department of Obstetrics and Gynaecology, Prince of Wales Hospital    
      Hong Kong, China

Sponsors and Collaborators
Hospital Authority, Hong Kong
Chinese University of Hong Kong

Investigators
Principal Investigator:     Tze Kin Lau, Prof     Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong    
  More Information


HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CRE-2003.118, HARECCTR0500014
First Received:   August 15, 2007
Last Updated:   June 16, 2008
ClinicalTrials.gov Identifier:   NCT00517140
Health Authority:   Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Pregnancy women with a scarred uterus due to previous caesarean section  

Study placed in the following topic categories:
Genital Diseases, Female
Pregnancy Complications
Uterine Rupture
Wounds and Injuries
Obstetric Labor Complications
Disorders of Environmental Origin
Uterine Diseases
Rupture
Cicatrix

ClinicalTrials.gov processed this record on October 07, 2008




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