Timing of Antibiotic Prophylaxis for Cesarean Deliveries

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-11-30

Brief Summary

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The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infectious morbidities when the extended spectrum prophylaxis given before the incision time vs. the time of cord clamp.

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Detailed Description

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Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting a prospective controlled randomized trial that will compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery will be eligible except for the patients with the diagnosis of chorioamnionitis. One group will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior to incision. The second group will receive the same antibiotics immediately after cord clamp. The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations, proven cases of neonatal infection. Secondary outcomes will be patients that required post procedure antibiotics, the duration of treatment for mother and neonate and the pattern of antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel flora.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group of patients that will receive antibiotics 30-60 minutes prior to incision

Group Type EXPERIMENTAL

Antibiotic

Intervention Type DRUG

Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

B

Group of patients that will receive antibiotics immediately after clamping the umbilical cord

Group Type ACTIVE_COMPARATOR

Antibiotic

Intervention Type DRUG

Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Interventions

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Antibiotic

Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Intervention Type DRUG

Antibiotic

Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All Patients undergoing cesarean delivery

Exclusion Criteria

* Patients diagnosed with chorioamnionitis at the time of decision
* Patients that require an emergency cesarean delivery
* Patients that decline participating on the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes