Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960970
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Tali Wajsfeld, RWJ Barnabas Health at Jersey City Medical Center

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.

Condition or disease Intervention/treatment Phase
Endometritis Cesarean Section; Infection Wound Infection Drug: Azithromycin 500 mg Drug: Mefoxin 2g Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: One-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once
Drug: Mefoxin 2g
Standard Prophylaxis
Other Name: Cefoxitin

Experimental: Two-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
Drug: Azithromycin 500 mg
Additional IV Azithromycin 500 mg to Standard Prophylaxis

Drug: Mefoxin 2g
Standard Prophylaxis
Other Name: Cefoxitin




Primary Outcome Measures :
  1. Rates of Endometritis [ Time Frame: 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.

  2. Rates of Wound Infection [ Time Frame: 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 Outcome Measures :
  1. Rates of Maternal Fever [ Time Frame: Up to 6 weeks after delivery ]
    Temperature equal or greater than 100.4F

  2. Rates of Maternal Postpartum Readmission or Unscheduled Visit [ Time Frame: Up to 6 weeks after delivery ]
    Admission to hospital or unscheduled appointment in additional to regular 1-week and 6-week postpartum visit

  3. Rates of Postpartum Antibiotic Use [ Time Frame: Up to 6 weeks after delivery ]
    Antibiotic use for any reason including other infections such as UTI and sepsis.

  4. Rates of Serious Adverse Events [ Time Frame: Up to 6 weeks after delivery ]
    MICU admission, thromboembolic events, sepsis, maternal death


Other Outcome Measures:
  1. Rates of Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: Up to 6 weeks after delivery ]
    Neonatal Intensive Care Unit (NICU) Admission rather than prematurity

  2. Rates of Neonatal Readmission [ Time Frame: Up to 6 weeks after delivery ]
    Hospital readmission within 6 weeks of birth



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960970


Contacts
Layout table for location contacts
Contact: Tali Wajsfeld, MD 2019152000 ext 2340 tali.wajsfeld@rwjbh.org

Locations
Layout table for location information
United States, New Jersey
Jersey City Medical Center Recruiting
Jersey City, New Jersey, United States, 07302
Contact: Tali Wajsfeld, MD    201-915-2340    tali.wajsfeld@rwjbh.org   
Sponsors and Collaborators
RWJ Barnabas Health at Jersey City Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Tali Wajsfeld, MD RWJ Barnabas Health at Jersey City Medical Center

Publications:

Layout table for additonal information
Responsible Party: Tali Wajsfeld, Principal Investigador, RWJ Barnabas Health at Jersey City Medical Center
ClinicalTrials.gov Identifier: NCT03960970     History of Changes
Other Study ID Numbers: Prophylaxis Trial
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tali Wajsfeld, RWJ Barnabas Health at Jersey City Medical Center:
Cesarean Delivery
Endometritis
Wound Infection
Azithromycin
Antibiotic Prophylaxis
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Wound Infection
Endometritis
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Azithromycin
Cefoxitin
Cefotaxime
Anti-Bacterial Agents
Anti-Infective Agents