Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

RWJ Barnabas Health at Jersey City Medical Center

Status and phase: Unknown; Phase 2

Conditions: Endometritis; Cesarean Section; Infection; Wound Infection

Treatments: Drug: Azithromycin 500 mg; Drug: Mefoxin 2g

Study type: Interventional

Funder types: Other

Identifiers

NCT03960970

Prophylaxis Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

One-drug Prophylaxis

Active Comparator group

Description:

Mefoxin 2g IV, Piggyback, once

Treatment:

Drug: Mefoxin 2g

Two-drug Prophylaxis

Experimental group

Description:

Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once

Treatment:

Drug: Mefoxin 2g

Drug: Azithromycin 500 mg