Conditions: Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: yes

Brief summary:
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:
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.

Arms:
arm 1: Group of patients that will receive antibiotics 30-60 minutes prior to incision arm 2: Group of patients that will receive antibiotics immediately after clamping the umbilical cord

Interventions: intervention 1: Antibiotic intervention 2: Antibiotic
Intervention descriptions: intervention 1: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously intervention 2: Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously

Protocol document: