Cesarean SectionNCT01808807
Factors Influencing Cesarean Section Rate: Does the Audit Still Work?
An observational study of Cesarean Section, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate. From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Read more about this study
- Who is it for?
- Ages 15 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- How many people
- 4,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Apr 2013
- 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 15 to 47 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: pregnant women who delivered in a medical center will be included retrospectively in this study
Who may be able to join
- All pregnant women who delivered in a medical center will be included retrospectively in this study
Who cannot join
- All pregnant women who delivered in a medical center will be included retrospectively in this study , no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate.
From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.
- Conditions
- Cesarean Section
- Keywords
- cesarean section rate, the cesarean section rate audit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cesarean section rate after audit | cesarean section rate after audit |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of the cesarean section rate audit
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808807
- Sponsor's protocol ID
- 101110-F
- Status last verified
- Mar 2013
- First submitted
- 11 Dec 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Cesarean Section Rate: Does the Audit Still Work?
- ClinicalTrials.gov ID
- NCT01808807
- Acronym / sponsor ID
- 101110-F
- Conditions
- Cesarean Section
- Keywords
- cesarean section rate, the cesarean section rate audit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 11 Mar 2013 (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.
To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate.
From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cesarean section rate after audit | – | –cesarean section rate after audit |
Who may qualify
- Ages
- 15 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pregnant women who delivered in a medical center will be included retrospectively in this study
Key inclusion criteria (1 listed)
- All pregnant women who delivered in a medical center will be included retrospectively in this study
Key exclusion criteria (1 listed)
- All pregnant women who delivered in a medical center will be included retrospectively in this study , no exclusion criteria
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
the impact of the cesarean section rate audit
Time frame: 1 month
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 19 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cesarean Section, run by Far Eastern Memorial 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 1 inclusion and 1 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 19 Aug 2013. 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.
What does the primary outcome measure?
the impact of the cesarean section rate audit (time frame: 1 month). 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 19 Aug 2013.