no Antibiotics for Elective Cesarean With Low Risk of Inf... | NCT02126228

Studies
no Antibiotics for Elective Cesarean With Low Risk of Infection

NCT02126228

Sponsor

Fanzhen Hong

Status

Completed

Last Update Posted

Apr 29, 2014Estimated

Enrollment

212Actual

Phase

Not provided

Conditions

Antibiotics , Elective Cesarean, China

Interventions

Not provided

Countries

China

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 23, 2014

First Submission Date that Met QC Criteria

Apr 27, 2014

First Posted Date

Apr 29, 2014Estimated

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

Apr 27, 2014

Last Update Posted Date

Apr 29, 2014Estimated

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

The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.

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

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Temperature		3days

Secondary Outcomes

Measure	Description	Time Frame
Postpartum hemorrhage volume estimates and Routine blood test.		3days

Other Outcomes

Measure	Description	Time Frame
Observation of puerperal infection	Incision healing;Intrauterine infection;Pelvic and abdominal infection;Infection of urinary system	30days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective cesarean
With normal temperature;
No signs of infection;
Normal degree of cleanliness in vaginal; .Normal amniotic fluid.

Exclusion Criteria:

Failure of vaginal delivery and emergency cesarean;
Premature rupture of membranes;
Antibiotics having been applied to 3 days before cesarean;
Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis;
Having infections in respiratory or urinary system before cesarean;
Placenta previa or placental abruption;
With medical and surgical complications;
BMI ≥ 30kg/m2;
Total blood loss more than 1000ml within 2 hours after cesarean

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

antibiotics group:202 none antibiotics group:212

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
YONGPING XU, MD.PhD	Obstetrics of 2nd Hospital of Shandong University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Hospital of Shandong University		Jinan	Shandong	250033	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20733474	Background	Committee opinion no. 465: antimicrobial prophylaxis for cesarean delivery: timing of administration. Obstet Gynecol. 2010 Sep;116(3):791-792. doi: 10.1097/AOG.0b013e3181f68086.