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Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

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ClinicalTrials.gov Identifier: NCT00517140
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : June 16, 2011
Chinese University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong

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.

Condition or disease Intervention/treatment
Pregnancy Cesarean Section Uterine Rupture Procedure: Repeat Caesaen section Procedure: vaginal delivery

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
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
Study Start Date : September 2003
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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

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

Department of Obstetrics and Gynaecology, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Chinese University of Hong Kong
Principal Investigator: Tze Kin Lau, Prof Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong

Additional Information:
ClinicalTrials.gov Identifier: NCT00517140     History of Changes
Other Study ID Numbers: CRE-2003.118
First Posted: August 16, 2007    Key Record Dates
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:
Uterine Rupture
Wounds and Injuries
Uterine Diseases
Genital Diseases, Female
Obstetric Labor Complications
Pregnancy Complications