Anesthesia; Adverse Effect, in Labor and DeliveryNCT03391648
Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery
An observational study of Anesthesia; Adverse Effect, in Labor and Delivery, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, in Labor and Delivery
- What is being tested?
- Observation
- How many people
- 505 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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: Parturients who undergo cesarean section
Who may be able to join
- all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016
Who cannot join
- missing data can't be collect during medical chart review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery: a Retrospective Study
Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation only
| Study group | Role | What they receive |
|---|---|---|
| Cesarean | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anesthesia-related adverse events
Measured: Within 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse Effect, in Labor and DeliveryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Chen Chang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391648
- Sponsor's protocol ID
- 106116-E
- Status last verified
- Feb 2019
- First submitted
- 30 Dec 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Anesthesia-related Adverse Events and Obstetric Complications After Cesarean Delivery: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03391648
- Acronym / sponsor ID
- 106116-E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- 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.
Recruit the parturients who underwent cesarean delivery at Far Eastern MemorialHospital during 2012-2016. After reviewing medical record related to the pregnancy, demographic data, prenatal exam, laboratory data, indication for cesarean section, perioperative events, etc. will be recorded. Analysis will be focused on incidence, temporal trend, and risk factors of anesthesia-related adverse events and obstetric complications.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean | – | Other: Observation |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parturients who undergo cesarean section
Key inclusion criteria (1 listed)
- all parturients underwent cesarean section at Far Eastern Memorial Hospital during 2012-2016
Key exclusion criteria (1 listed)
- missing data can't be collect during medical chart review
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 |
|---|---|---|
| ObservationObservation only | Other | Cesarean |
Primary outcome
Incidence of anesthesia-related adverse events
Time frame: Within 42 days 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 15 Feb 2019.
- Individual participant dataSharing planned: No
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 Anesthesia; Adverse Effect, in Labor and Delivery, 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 15 Feb 2019. 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?
Incidence of anesthesia-related adverse events (time frame: Within 42 days 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 15 Feb 2019.