NCT03960970

Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: RWJ Barnabas Health at Jersey City Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometritis
• Cesarean Section; Infection
• Wound Infection

Interventions

Type	Name	Description
DRUG	Azithromycin 500 mg	Additional IV Azithromycin 500 mg to Standard Prophylaxis
DRUG	Mefoxin 2g	Standard Prophylaxis

Timeline

• Start date: 2019-09-15
• Primary completion: 2019-09-30
• Completion: 2020-11-30
• First posted: 2019-05-23
• Last updated: 2019-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study