no Antibiotics for Elective Cesarean With Low Risk of Infection

NCT ID: NCT02126228

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Antibiotics , Elective Cesarean, China

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fanzhen Hong

OTHER

Sponsor Role lead

Responsible Party

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Fanzhen Hong

Obstetrics of 2nd Hopital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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YONGPING XU, MD.PhD

Role: STUDY_DIRECTOR

Obstetrics of 2nd Hospital of Shandong University

Locations

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2nd Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 20733474 (View on PubMed)

Other Identifiers

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2ndhsdu-ob

Identifier Type: -

Identifier Source: org_study_id

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