Recruiting
Phase 2

Antibiotic Prophylaxis

Sponsor:

RWJ Barnabas Health at Jersey City Medical Center

Code:

NCT03960970

Conditions

Endometritis

Cesarean Section; Infection

Wound Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azithromycin 500 mg

Mefoxin 2g

Study Details

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.

Conditions

Endometritis

Cesarean Section; Infection

Wound Infection

Study ID

NCT03960970

Start date

Sep 15, 2019

Status verified date

Sep, 2019

Completion date

Nov 30, 2020

Anticipated

Primary completion date

Sep 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: One-drug Prophylaxis

Mefoxin 2g IV, Piggyback, once

experimental: Two-drug Prophylaxis

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

Interventions

Azithromycin 500 mg

Additional IV Azithromycin 500 mg to Standard Prophylaxis

Mefoxin 2g

Standard Prophylaxis

Primary outcome measure

  • Rates of Endometritis [ Time Frame: Up to 6 weeks after delivery ]
  • Rates of Wound Infection [ Time Frame: Up to 6 weeks after delivery ]

Central Contacts and Locations

Central contacts

Tali Wajsfeld, MD

2019152000tali.wajsfeld@rwjbh.org

Locations

Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Tali Wajsfeld, MD

201-915-2340tali.wajsfeld@rwjbh.org

More Information

Sponsor

RWJ Barnabas Health at Jersey City Medical Center

Last update posted

Sep 17, 2019

Last verified

Sep, 2019

Keywords

  • Cesarean Delivery
  • Endometritis
  • Wound Infection
  • Azithromycin
  • Antibiotic Prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RWJ Barnabas Health at Jersey City Medical Center on 2019-09-17.