Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

NCT ID: NCT00517140

Last Updated: 2011-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2007-04-30

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.

Conditions

Pregnancy; Cesarean Section; Uterine Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Repeat Caesaen section

Intervention Type: PROCEDURE

vaginal delivery

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Tze Kin Lau, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong

Locations

Department of Obstetrics and Gynaecology, Prince of Wales Hospital

Hong Kong, , China

Countries

China

Other Identifiers

HARECCTR0500014

Identifier Type: -

Identifier Source: secondary_id

CRE-2003.118

Identifier Type: -

Identifier Source: org_study_id