Vaginal Birth After Caesarean Section – Effect on Maternal Psychosocial Function

Vaginal Birth After Cesarean Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294411
• Other study ID #: 4423/03M
• Status: Completed
• Phase: N/A
• First received: February 21, 2006
• Last updated: February 21, 2006
• Start date: December 2003

Study information

• Verified date: February 2006
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research 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. What we do know is that antenatal depression and unplanned caesarean section are major risk factors for postpartum depression, which in turn is the major cause of maternal mortality in many developed countries including Hong Kong. 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. The Hypothesis is that there is a significant difference in psychosocial function between these 2 groups of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women who agree for vaginal birth after prior cesarean section and who had no previous history of vaginal delivery

Exclusion Criteria:

• Inability or unwillingness to give informed consent. Multiple pregnancy, more than one previous caesarean section, and a previous classical caesarean section, presence of other contra-indications to vaginal birth

Study Design

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

Related Conditions & MeSH terms

• Vaginal Birth After Cesarean

Intervention

Procedure:
• elective cesarean section

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Health Questionnaire (GHQ)
Secondary	State-Trait Anxiety Inventory
Secondary	Beck Depression Inventory
Secondary	Edinburgh Postnatal Depression Scale
Secondary	Client Satisfaction Questionnaire
Secondary	MRC Social Performance Schedule
Secondary	WHO Quality of Life questionnaire