Complications: Urgent C Section VS Elective C Section | NCT01524107

Studies
Complications: Urgent C Section VS Elective C Section

NCT01524107

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Dec 20, 2016Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Urgent Caesarian Section Secondary to Cord Prolapse

Interventions

Not provided

Countries

Israel

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 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Jan 30, 2012

First Submission Date that Met QC Criteria

Jan 30, 2012

First Posted Date

Feb 1, 2012Estimated

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 18, 2016

Last Update Posted Date

Dec 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women undergoing urgent Caesarian Section for Prolapsed Cord.
women undergoing Elective Caesarian Section.

Exclusion Criteria:

preterm birth
multiple gestation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women undergoing Urgent Caesarian Section for Prolapsed Cord and women undergoing Elective Caesarian Section at Hadassah Medical Center-Har HaTzofim.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Drorith Hochner-Celnikier, MD	Contact	00 972 2 5844400		hochner@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Drorith Hochner-Celnikier, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel