Endometritis, Cesarean Section; Infection, Wound Infection
Conditions
Keywords
Cesarean Delivery, Endometritis, Wound Infection, Azithromycin, Antibiotic Prophylaxis
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.
Interventions
Additional IV Azithromycin 500 mg to Standard Prophylaxis
DRUGMefoxin 2g
Standard Prophylaxis
Sponsors
RWJ Barnabas Health at Jersey City Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pregnant patients admitted to Labor and Delivery unit between June 2019 and July 2020 will be randomized to received either standard prophylaxis or azithromycin and cephalosporin for preoperative prophylaxis after inclusion and exclusion criteria are met and informed consent for participation is signed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Serious Adverse Events | Up to 6 weeks after delivery | MICU admission, thromboembolic events, sepsis, maternal death |
| Rates of Postpartum Antibiotic Use | Up to 6 weeks after delivery | Antibiotic use for any reason including other infections such as UTI and sepsis. |
| Rates of Maternal Fever | Up to 6 weeks after delivery | Temperature equal or greater than 100.4F |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of Neonatal Intensive Care Unit (NICU) Admission | Up to 6 weeks after delivery | Neonatal Intensive Care Unit (NICU) Admission rather than prematurity |
| Rates of Neonatal Readmission | Up to 6 weeks after delivery | Hospital readmission within 6 weeks of birth |
Countries
United States
Contacts
Primary ContactTali Wajsfeld, MD
Outcome results
None listed