PregnancyNCT00517140
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
A study testing Repeat Caesaen section and vaginal delivery in people with Pregnancy and Cesarean Section, run by Hospital Authority, Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Uterine Rupture
- What is being tested?
- Repeat Caesaen section and vaginal delivery
- Type of treatment
- Surgery or procedure
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- Sep 2003to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- All women who:
- Have one prior caesarean section
- No prior vaginal delivery and
- Agree for either vaginal delivery or elective caesarean section
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynaecology, Prince of Wales Hospital
Hong Kong
About this study
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. 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.
- Conditions
- Pregnancy, Cesarean Section, Uterine Rupture
- Being tested
- Repeat Caesaen section, vaginal delivery
- Keywords
- Pregnancy women with a scarred uterus due to previous caesarean section
- Medical subject headings
- Uterine Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat Caesaen sectionProcedure or surgery
vaginal deliveryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pscyiatric morbidity
Measured: after delivery
Secondary outcomes (1)
Psychosocial function
Measured: 3 and 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startSep 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Chinese University of Hong Kong
- Investigators
- Tze Kin Lau, Prof, Principal investigator, Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517140
- Sponsor's protocol ID
- CRE-2003.118
- Other IDs
- HARECCTR0500014
- Status last verified
- Jun 2011
- First submitted
- 15 Aug 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function
- ClinicalTrials.gov ID
- NCT00517140
- Acronym / sponsor ID
- CRE-2003.118
- Conditions
- Pregnancy, Cesarean Section, Uterine Rupture
- Keywords
- Pregnancy women with a scarred uterus due to previous caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Chinese University of Hong Kong
- Study start
- Sep 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have one prior caesarean section
- No prior vaginal delivery and
- Agree for either vaginal delivery or elective caesarean section
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeat Caesaen section | Procedure or surgery | – |
| vaginal delivery | Procedure or surgery | – |
Primary outcome
pscyiatric morbidity
Time frame: after delivery
1 secondary outcome
Psychosocial function
Time frame: 3 and 6 months after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Kin Lau, Prof principal investigator
Department of Obstetrics and Gynaecology, The Chinese Univerisity of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeat Caesaen section and vaginal delivery in people with Pregnancy and Cesarean Section, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pscyiatric morbidity (time frame: after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.