Timing of Antibiotic Prophylaxis for Cesarean Deliveries

University of Florida

Status: Completed

Conditions: Infection

Treatments: Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT00805545

C/S- Antibiotics

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Antibiotic

Drug: Antibiotic

B

Active Comparator group

Description:

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

Treatment:

Drug: Antibiotic

Drug: Antibiotic