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Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial

NCT ID: NCT01248078

Last Updated: 2010-11-25

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

Clinical Phase

NA

Total Enrollment

1112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-01-31

Brief Summary

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In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping

Detailed Description

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Background. Perioperative antibiotic prophylaxis during elective cesarean section at term to reduce postoperative maternal infectious morbidity is generally used but may not be efficient based on the available data. Also, the optimal timing of prophylactic antibiotic administration is unclear.

Methods. The investigators compared the effectiveness of cefazolin, administered before skin incision versus after umbilical cord clamping versus placebo in a three-arm randomized trial. The primary endpoint of the study was postoperative infectious morbidity, defined as wound infection, endometritis, or urinary tract infection. Results: The primary outcome was observed in 18/370 women in group 1 (4.9%) and in 14/371 women in group 2 (3.8%), whereas it was noted in 45/371 women in group 3 (12.1%; p\<0.001 for group 1 vs. group 3; p\<0.001 for group 2 vs. group 3; p\<0.001 for group 1 vs. group 2 vs. group 3). The number needed to treat to avoid one primary outcome was 13. Comparing groups 1 and 2, there was no statistically significant difference regarding the primary outcome (p=0.6).

Conclusions. In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping.

Conditions

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Elective Cesarean Section

Keywords

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elective cesarean section antibiotic prophylaxis cefazoline wound infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cefazolin A

administered before skin incision

Group Type ACTIVE_COMPARATOR

Keflex

Intervention Type DRUG

2g of i.v. cefazolin singleshot administered before skin incision

Cefazolin B

after umbilical cord clamping

Group Type ACTIVE_COMPARATOR

Keflex

Intervention Type DRUG

2g of i.v. cefazolin singleshot administered after umbilical cord clamping

saline solution

administered before skin incision

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

100cc administered before skin incision

Interventions

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Keflex

2g of i.v. cefazolin singleshot administered before skin incision

Intervention Type DRUG

Keflex

2g of i.v. cefazolin singleshot administered after umbilical cord clamping

Intervention Type DRUG

saline solution

100cc administered before skin incision

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Elective cesarean section at term Patientin \>18 years Informed consent NO known allergy to cefazolin NO exposure to any antibiotic agent within 1 week prior to delivery

Exclusion Criteria

\- cesarean section before week 37 cephalosporin allergy age less than 18 years exposure to any antibiotic agent within 1 week prior to delivery
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Witt A, Doner M, Petricevic L, Berger A, Germann P, Heinze G, Tempfer C. Antibiotic prophylaxis before surgery vs after cord clamping in elective cesarean delivery: a double-blind, prospective, randomized, placebo-controlled trial. Arch Surg. 2011 Dec;146(12):1404-9. doi: 10.1001/archsurg.2011.725.

Reference Type DERIVED
PMID: 22184305 (View on PubMed)

Other Identifiers

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226/2003

Identifier Type: -

Identifier Source: org_study_id