Vaginal Birth After Caesarean Section – Effect on Maternal Psychosocial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294411
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : February 22, 2006
Information provided by:
Chinese University of 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. 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 or disease Intervention/treatment Phase
Vaginal Birth After Cesarean Procedure: elective cesarean section Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. General Health Questionnaire (GHQ)

Secondary Outcome Measures :
  1. State-Trait Anxiety Inventory
  2. Beck Depression Inventory
  3. Edinburgh Postnatal Depression Scale
  4. Client Satisfaction Questionnaire
  5. MRC Social Performance Schedule
  6. WHO Quality of Life questionnaire

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:

  • 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

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 identifier (NCT number): NCT00294411

Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Tze Kin LAU, MD Chinese University of Hong Kong Identifier: NCT00294411     History of Changes
Other Study ID Numbers: 4423/03M
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: February 2006