The Timing of Prophylactic Antibiotics in Cesarean Sectio... | NCT00133029

Studies
The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity

NCT00133029

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Aug 15, 2016Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Cesarean Section

Interventions

Timing of prophylactic antibiotic administration

Countries

United States

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 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Aug 19, 2005

First Submission Date that Met QC Criteria

Aug 19, 2005

First Posted Date

Aug 22, 2005Estimated

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 12, 2016

Last Update Posted Date

Aug 15, 2016Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Timing of prophylactic antibiotic administration	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age > 36 weeks
Ability to understand requirements of the study
Elective/non-emergent cesarean section selected as route of delivery by treating physicians

Exclusion Criteria:

Known fetal anomaly
Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
Overt maternal intrapartum infection requiring antibiotics
Prolonged rupture of membranes (>18 hours)

Accepts Healthy Volunteers

Not provided

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George A. Macones, MD, MSCE	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States