Intrapartum Fever and Histopathological Placental Findings | NCT01175187

Studies
Intrapartum Fever and Histopathological Placental Findings

NCT01175187

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Aug 10, 2010Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Histological Placental Inflamation With or Without Fever

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Aug 2, 2010

First Submission Date that Met QC Criteria

Aug 2, 2010

First Posted Date

Aug 4, 2010Estimated

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

Aug 8, 2010

Last Update Posted Date

Aug 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings

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

Retention

Not provided

Description

Enrollment

200Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:epidural with and without fever

Exclusion Criteria:

Patients with infectious backgroud or prilinged PROM

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

200 normal deliveries

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shmuel evron, md	Tel Aviv University	Principal Investigator

Locations

Not provided

Label	Type	Description	Intervention Names
EPIDURAL FEVER
EPIDURAL WITHOUT FEVER
GROUP 1: EPIDURAL FEVER . GROUP 2 EPIDURAL WITHOUT FEVER