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Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

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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

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date September 17, 2019
Estimated Study Start Date  ICMJE September 15, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03960970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Rates of Maternal Fever [ Time Frame: Up to 6 weeks after delivery ]
    Temperature equal or greater than 100.4F
  • 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
  • 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.
  • Rates of Serious Adverse Events [ Time Frame: Up to 6 weeks after delivery ]
    MICU admission, thromboembolic events, sepsis, maternal death
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Maternal Fever [ Time Frame: Up to 6 weeks after delivery ]
    Temperature equal or greater than 100.4F
  • 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
  • Maternal Postpartum Antibiotic Use [ Time Frame: Up to 6 weeks after delivery ]
    Antibiotic use for any reason including other infections such as UTI and sepsis.
  • Maternal Serious Adverse Events [ Time Frame: Up to 6 weeks after delivery ]
    MICU admission, thromboembolic events, sepsis, maternal death
Current Other Pre-specified Outcome Measures
 (submitted: May 22, 2019)
  • 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
  • Rates of Neonatal Readmission [ Time Frame: Up to 6 weeks after delivery ]
    Hospital readmission within 6 weeks of birth
Original Other Pre-specified Outcome Measures
 (submitted: May 21, 2019)
  • Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: Up to 6 weeks after delivery ]
    Neonatal Intensive Care Unit (NICU) Admission rather than prematurity
  • Neonatal Readmission [ Time Frame: Up to 6 weeks after delivery ]
    Hospital readmission within 6 weeks of birth
 
Descriptive Information
Brief Title  ICMJE Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
Official Title  ICMJE Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Endometritis
  • Cesarean Section; Infection
  • Wound Infection
Intervention  ICMJE
  • Drug: Azithromycin 500 mg
    Additional IV Azithromycin 500 mg to Standard Prophylaxis
  • Drug: Mefoxin 2g
    Standard Prophylaxis
    Other Name: Cefoxitin
Study Arms  ICMJE
  • Active Comparator: One-drug Prophylaxis
    Mefoxin 2g IV, Piggyback, once
    Intervention: Drug: Mefoxin 2g
  • Experimental: Two-drug Prophylaxis
    Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
    Interventions:
    • Drug: Azithromycin 500 mg
    • Drug: Mefoxin 2g
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tali Wajsfeld, MD 2019152000 ext 2340 tali.wajsfeld@rwjbh.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960970
Other Study ID Numbers  ICMJE Prophylaxis Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tali Wajsfeld, RWJ Barnabas Health at Jersey City Medical Center
Study Sponsor  ICMJE RWJ Barnabas Health at Jersey City Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tali Wajsfeld, MD RWJ Barnabas Health at Jersey City Medical Center
PRS Account RWJ Barnabas Health at Jersey City Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP