NCT00294411

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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

February 22, 2006

Status Verified

February 1, 2006

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

Vaginal Birth After Cesarean

Outcome Measures

Primary Outcomes (1)

  • General Health Questionnaire (GHQ)

Secondary Outcomes (6)

  • State-Trait Anxiety Inventory

  • Beck Depression Inventory

  • Edinburgh Postnatal Depression Scale

  • Client Satisfaction Questionnaire

  • MRC Social Performance Schedule

  • +1 more secondary outcomes

Interventions

elective cesarean sectionPROCEDURE

Eligibility Criteria

Age0 Years+
Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tze Kin LAU, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

December 1, 2003

Last Updated

February 22, 2006

Record last verified: 2006-02