Anesthetic Considerations for Repeat Cesarean Section - a... | NCT04693572

Studies
Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study

NCT04693572

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

Jan 5, 2021Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Anesthesia
Pregnancy, High Risk
Pregnancy Related

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2021Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Dec 31, 2020

First Submission Date that Met QC Criteria

Dec 31, 2020

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2020

Last Update Posted Date

Jan 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jacob Weinstein, MD MSc, Clinical Fellow, Shaare Zedek Medical CenterPrincipal Investigator

Lead Sponsor

Shaare Zedek Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Label	Type	Description	Intervention Names
Parturients undergoing repeated caesarean sectiona

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of sections performed under general anesthesia		1 day
Percentage of in-surgery conversion from regional to general anesthesia		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parturients undergoing repeated caesarean section.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Parturients undergoing repeated caesarean section.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jacob Weinstein, MD	Contact	+972544302909		jacobweins@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided