- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294411
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
February 21, 2006 updated by: Chinese University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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General Health Questionnaire (GHQ)
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Secondary Outcome Measures
Outcome Measure |
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Beck Depression Inventory
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Client Satisfaction Questionnaire
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State-Trait Anxiety Inventory
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Edinburgh Postnatal Depression Scale
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MRC Social Performance Schedule
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WHO Quality of Life questionnaire
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tze Kin LAU, MD, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Registration Dates
First Submitted
February 21, 2006
First Submitted That Met QC Criteria
February 21, 2006
First Posted (Estimate)
February 22, 2006
Study Record Updates
Last Update Posted (Estimate)
February 22, 2006
Last Update Submitted That Met QC Criteria
February 21, 2006
Last Verified
February 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- 4423/03M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.