Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.
Cesarean deliveries are the most common surgical procedure performed in the United States, and scheduled cesarean deliveries account for at least 40% of all cesarean deliveries every year. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin given within 60 minutes of skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is not only cost-effective but reduces overall rates of endometritis and wound infection. Azithromycin provides effective coverage against Ureaplasma, commonly associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients. No increase in neonatal morbidity was noted with adjunctive azithromycin prophylaxis, including adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
800
Additional IV Azithromycin 500 mg to Standard Prophylaxis
Standard Prophylaxis
Jersey City Medical Center
Jersey City, New Jersey, United States
RECRUITINGRates of Endometritis
Presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \[100.4°F\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus.
Time frame: Up to 6 weeks after delivery
Rates of Wound Infection
Presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, abscess or breakdown alone in the absence of the preceding signs did not constitute infection.
Time frame: Up to 6 weeks after delivery
Rates of Maternal Fever
Temperature equal or greater than 100.4F
Time frame: Up to 6 weeks after delivery
Rates of Maternal Postpartum Readmission or Unscheduled Visit
Admission to hospital or unscheduled appointment in additional to regular 1-week and 6-week postpartum visit
Time frame: Up to 6 weeks after delivery
Rates of Postpartum Antibiotic Use
Antibiotic use for any reason including other infections such as UTI and sepsis.
Time frame: Up to 6 weeks after delivery
Rates of Serious Adverse Events
MICU admission, thromboembolic events, sepsis, maternal death
Time frame: Up to 6 weeks after delivery
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