Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

• Status: Unknown status
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWJ Barnabas Health at Jersey City Medical Center
• Treatments: Azithromycin; Cefotaxime; Cefoxitin

Criteria

Inclusion Criteria:

• Pregnant women 18 years or older

• Women undergoing primary or repeat cesarean delivery

• Singleton gestation

• Gestational age greater than 34 weeks

• Pregnant patients undergoing scheduled cesarean delivery

• Intact membranes

• Non-laboring

• Signed informed consent

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.