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Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

NCT03960970 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-09-17

No results posted yet for this study

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

Interventions

DRUG

Azithromycin 500 mg

Additional IV Azithromycin 500 mg to Standard Prophylaxis

DRUG

Mefoxin 2g

Standard Prophylaxis

Sponsors & Collaborators

  • RWJ Barnabas Health at Jersey City Medical Center

    lead OTHER

Principal Investigators

  • Tali Wajsfeld, MD · RWJ Barnabas Health at Jersey City Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2019-09-30
Completion
2020-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960970 on ClinicalTrials.gov