Vaginal Birth After Caesarean Section – Effect on Maternal Psychosocial Function

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00294411
First received: February 21, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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. 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.


Condition Intervention
Vaginal Birth After Cesarean
Procedure: elective cesarean section

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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • General Health Questionnaire (GHQ)

Secondary Outcome Measures:
  • State-Trait Anxiety Inventory
  • Beck Depression Inventory
  • Edinburgh Postnatal Depression Scale
  • Client Satisfaction Questionnaire
  • MRC Social Performance Schedule
  • WHO Quality of Life questionnaire

Study Start Date: December 2003
  Eligibility

Genders Eligible for Study:   Female
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00294411

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Tze Kin LAU, MD Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294411     History of Changes
Other Study ID Numbers: 4423/03M
Study First Received: February 21, 2006
Last Updated: February 21, 2006
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014