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Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517140
First Posted: August 16, 2007
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chinese University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00517140     History of Changes
Other Study ID Numbers: CRE-2003.118
HARECCTR0500014
First Submitted: August 15, 2007
First Posted: August 16, 2007
Last Update Posted: June 16, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
Rupture
Uterine Rupture
Wounds and Injuries
Uterine Diseases
Genital Diseases, Female
Obstetric Labor Complications
Pregnancy Complications