Timing of Antibiotic Prophylaxis for Cesarean Deliveries

Study Overview
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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.

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.

Official Title
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The Timing of Antibiotic Prophylaxis for Cesarean Delivery

Conditions
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Infection

Intervention / Treatment
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* Drug: Antibiotic
* Drug: Antibiotic


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Group of patients that will receive antibiotics 30-60 minutes prior to incision | Drug: Antibiotic<br>* Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously<br>|
| Active Comparator: B<br>Group of patients that will receive antibiotics immediately after clamping the umbilical cord | Drug: Antibiotic<br>* Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometritis and Wound Infection | In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby. | Patients were followed from the time of surgery until 6 weeks postpartum. |