AnesthesiaNCT04693572
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study
An observational study of Anesthesia and Pregnancy, High Risk, run by Shaare Zedek Medical Center.
Trial summary
The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pregnancy, High Risk, Pregnancy Related
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2021
- How long will I take part?
- 4 Weeks
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parturients undergoing repeated caesarean section.
Who may be able to join
- Parturients undergoing repeated caesarean section.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.
Read the detailed description
Data concerning anesthetic considerations and outcomes will be gathered from the electronic medical records of all parturients undergoing repeated caesarean sections in our medical center. the collected data will be stored anonymously.
Different aspects of anesthetic considerations and outcomes will be compared and subjected to analysis.
- Conditions
- Anesthesia, Pregnancy, High Risk, Pregnancy Related
- Keywords
- Caesarian Section, Repeated Caesarian Section, Anesthesia
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 |
|---|---|---|
| Parturients undergoing repeated caesarean sectiona | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of sections performed under general anesthesia
Measured: 1 day
Percentage of in-surgery conversion from regional to general anesthesia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Weinstein, MD MSc, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693572
- Sponsor's protocol ID
- 0415-20-SZMC
- Status last verified
- Dec 2020
- First submitted
- 31 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study
- ClinicalTrials.gov ID
- NCT04693572
- Acronym / sponsor ID
- 0415-20-SZMC
- Conditions
- Anesthesia, Pregnancy, High Risk, Pregnancy Related
- Keywords
- Caesarian Section, Repeated Caesarian Section, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.
Detailed description
Data concerning anesthetic considerations and outcomes will be gathered from the electronic medical records of all parturients undergoing repeated caesarean sections in our medical center. the collected data will be stored anonymously.
Different aspects of anesthetic considerations and outcomes will be compared and subjected to analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients undergoing repeated caesarean sectiona | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parturients undergoing repeated caesarean section.
Key inclusion criteria (1 listed)
- Parturients undergoing repeated caesarean section.
Key exclusion criteria (1 listed)
- -
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
Percentage of sections performed under general anesthesia
Time frame: 1 day
Percentage of in-surgery conversion from regional to general anesthesia
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Pregnancy, High Risk, run by Shaare Zedek Medical Center.
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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Weinstein, MD (+972544302909, jacobweins@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sections performed under general anesthesia (time frame: 1 day). The study lists 2 primary outcomes in all. 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 5 Jan 2021.