Caesarean SectionNCT01210300
Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section
An observational study of Caesarean Section, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Caesarean Section
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Sep 2010
- Phase
- Observational
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women
Who may be able to join
- Have had a previous CS with a live baby
- Currently at 34 to 38 weeks of pregnancy
- Medically eligible for a VBAC
- Have chosen to have a natural birth
- 20 years old and over
- Able to converse in Mandarin and/or Taiwanese
Who cannot join
- Previous myomectomy
- Previous classical caesarean section
- Two previous caesarean section
- Pregnant with complications
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth complications. However, there is limited information about Taiwanese women's decision regarding VBAC and their participation in decision-making. There is also a gap in literature about information for women about CS and VBAC.
Read the detailed description
Ajzen's Theory of Planned Behaviour will theoretically underpin the study. A qualitative descriptive design using purposive sampling of 20 Taiwanese pregnant women who have previously had a CS with a live baby will be recruited from Chang Gung Memorial Hospital in Taiwan. In-depth interviews will be carried out in three phases: (1) between 34 weeks to 38 weeks of women's pregnancy; (2) on the third day after childbirth; and (3) at the fourth week after birth, the end of confinement. Boyatzis' Data Driven approach will be adopted to thematically analyze the data.
- Conditions
- Caesarean Section
- Keywords
- caesarean section, vaginal birth after caesarean section, repeat caesarean section, childbirth expectation, childbirth experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Man Chen, Principal investigator, Department of Nursing, Chang Gung Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210300
- Sponsor's protocol ID
- 99038
- Status last verified
- Apr 2011
- First submitted
- 26 Sep 2010
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section
- ClinicalTrials.gov ID
- NCT01210300
- Acronym / sponsor ID
- 99038
- Conditions
- Caesarean Section
- Keywords
- caesarean section, vaginal birth after caesarean section, repeat caesarean section, childbirth expectation, childbirth experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Sep 2010 (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 (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth complications. However, there is limited information about Taiwanese women's decision regarding VBAC and their participation in decision-making. There is also a gap in literature about information for women about CS and VBAC.
Detailed description
Ajzen's Theory of Planned Behaviour will theoretically underpin the study. A qualitative descriptive design using purposive sampling of 20 Taiwanese pregnant women who have previously had a CS with a live baby will be recruited from Chang Gung Memorial Hospital in Taiwan. In-depth interviews will be carried out in three phases: (1) between 34 weeks to 38 weeks of women's pregnancy; (2) on the third day after childbirth; and (3) at the fourth week after birth, the end of confinement. Boyatzis' Data Driven approach will be adopted to thematically analyze the data.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (6 listed)
- Have had a previous CS with a live baby
- Currently at 34 to 38 weeks of pregnancy
- Medically eligible for a VBAC
- Have chosen to have a natural birth
- 20 years old and over
Key exclusion criteria (4 listed)
- Previous myomectomy
- Previous classical caesarean section
- Two previous caesarean section
- Pregnant with complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 26 Apr 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.
Mei-Man Chen principal investigator
Department of Nursing, Chang Gung Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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 26 Apr 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 Taiwan. 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.
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 26 Apr 2011.