Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

Phase 2

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Maternal age < 18 years
Multi-fetal gestation
Known allergy to cephalosporin or azithromycin
Patient unwilling or unable to provide consent
Diagnosis of rupture of membranes
Intraamniotic infection, or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
Immunocompromising medical conditions: HIV positive with CD4 count below 200, chronic steroid use, current diagnosis of cancer and/or chemotherapy age use
Emergent cesarean precluding consent or availability of study medication
Need for hysterectomy at time of delivery
Use of antibiotic in the 72 hours prior to admission, with exception to patient receiving antibiotics for GBS
Inability to contact patient on postpartum period.

Arm && Interventions

Group	Intervention	Description
One-drug Prophylaxis	Mefoxin 2g	Mefoxin 2g IV, Piggyback, once
Two-drug Prophylaxis	Azithromycin 500 mg	Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
Two-drug Prophylaxis	Mefoxin 2g	Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once

Primary Outcome Measures

Name	Time	Method
Rates of Endometritis	Up to 6 weeks after delivery	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.
Rates of Wound Infection	Up to 6 weeks after delivery	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.

Secondary Outcome Measures

Name	Time	Method
Rates of Maternal Fever	Up to 6 weeks after delivery	Temperature equal or greater than 100.4F
Rates of Serious Adverse Events	Up to 6 weeks after delivery	MICU admission, thromboembolic events, sepsis, maternal death
Rates of Maternal Postpartum Readmission or Unscheduled Visit	Up to 6 weeks after delivery	Admission to hospital or unscheduled appointment in additional to regular 1-week and 6-week postpartum visit
Rates of Postpartum Antibiotic Use	Up to 6 weeks after delivery	Antibiotic use for any reason including other infections such as UTI and sepsis.

Locations (1): Jersey City Medical Center
🇺🇸
Jersey City, New Jersey, United States