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Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

Primary Purpose

Endometritis, Cesarean Section; Infection, Wound Infection

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azithromycin 500 mg
Mefoxin 2g
Sponsored by
RWJ Barnabas Health at Jersey City Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometritis focused on measuring Cesarean Delivery, Endometritis, Wound Infection, Azithromycin, Antibiotic Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jersey City Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

One-drug Prophylaxis

Two-drug Prophylaxis

Arm Description

Mefoxin 2g IV, Piggyback, once

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

Outcomes

Primary Outcome Measures

Rates of Endometritis
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
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

Rates of Maternal Fever
Temperature equal or greater than 100.4F
Rates of Maternal Postpartum Readmission or Unscheduled Visit
Admission to hospital or unscheduled appointment in additional to regular 1-week and 6-week postpartum visit
Rates of Postpartum Antibiotic Use
Antibiotic use for any reason including other infections such as UTI and sepsis.
Rates of Serious Adverse Events
MICU admission, thromboembolic events, sepsis, maternal death

Full Information

First Posted
May 21, 2019
Last Updated
September 15, 2019
Sponsor
RWJ Barnabas Health at Jersey City Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03960970
Brief Title
Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
Official Title
Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2019 (Anticipated)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWJ Barnabas Health at Jersey City Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis, Cesarean Section; Infection, Wound Infection
Keywords
Cesarean Delivery, Endometritis, Wound Infection, Azithromycin, Antibiotic Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One-drug Prophylaxis
Arm Type
Active Comparator
Arm Description
Mefoxin 2g IV, Piggyback, once
Arm Title
Two-drug Prophylaxis
Arm Type
Experimental
Arm Description
Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
Intervention Type
Drug
Intervention Name(s)
Azithromycin 500 mg
Intervention Description
Additional IV Azithromycin 500 mg to Standard Prophylaxis
Intervention Type
Drug
Intervention Name(s)
Mefoxin 2g
Other Intervention Name(s)
Cefoxitin
Intervention Description
Standard Prophylaxis
Primary Outcome Measure Information:
Title
Rates of Endometritis
Description
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.
Time Frame
Up to 6 weeks after delivery
Title
Rates of Wound Infection
Description
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.
Time Frame
Up to 6 weeks after delivery
Secondary Outcome Measure Information:
Title
Rates of Maternal Fever
Description
Temperature equal or greater than 100.4F
Time Frame
Up to 6 weeks after delivery
Title
Rates of Maternal Postpartum Readmission or Unscheduled Visit
Description
Admission to hospital or unscheduled appointment in additional to regular 1-week and 6-week postpartum visit
Time Frame
Up to 6 weeks after delivery
Title
Rates of Postpartum Antibiotic Use
Description
Antibiotic use for any reason including other infections such as UTI and sepsis.
Time Frame
Up to 6 weeks after delivery
Title
Rates of Serious Adverse Events
Description
MICU admission, thromboembolic events, sepsis, maternal death
Time Frame
Up to 6 weeks after delivery
Other Pre-specified Outcome Measures:
Title
Rates of Neonatal Intensive Care Unit (NICU) Admission
Description
Neonatal Intensive Care Unit (NICU) Admission rather than prematurity
Time Frame
Up to 6 weeks after delivery
Title
Rates of Neonatal Readmission
Description
Hospital readmission within 6 weeks of birth
Time Frame
Up to 6 weeks after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tali Wajsfeld, MD
Phone
2019152000
Ext
2340
Email
tali.wajsfeld@rwjbh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tali Wajsfeld, MD
Organizational Affiliation
RWJ Barnabas Health at Jersey City Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jersey City Medical Center
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tali Wajsfeld, MD
Phone
201-915-2340
Email
tali.wajsfeld@rwjbh.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19300334
Citation
Tita ATN, Rouse DJ, Blackwell S, Saade GR, Spong CY, Andrews WW. Emerging concepts in antibiotic prophylaxis for cesarean delivery: a systematic review. Obstet Gynecol. 2009 Mar;113(3):675-682. doi: 10.1097/AOG.0b013e318197c3b6.
Results Reference
background
PubMed Identifier
12798523
Citation
Andrews WW, Hauth JC, Cliver SP, Savage K, Goldenberg RL. Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis. Obstet Gynecol. 2003 Jun;101(6):1183-9. doi: 10.1016/s0029-7844(03)00016-4.
Results Reference
background
PubMed Identifier
28178058
Citation
Boggess KA, Tita A, Jauk V, Saade G, Longo S, Clark EAS, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Blackwell S, Beamon C, Szychowski JM, Andrews W; Cesarean Section Optimal Antibiotic Prophylaxis Trial Consortium. Risk Factors for Postcesarean Maternal Infection in a Trial of Extended-Spectrum Antibiotic Prophylaxis. Obstet Gynecol. 2017 Mar;129(3):481-485. doi: 10.1097/AOG.0000000000001899.
Results Reference
background
PubMed Identifier
27682034
Citation
Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
Results Reference
background
PubMed Identifier
7898825
Citation
Andrews WW, Shah SR, Goldenberg RL, Cliver SP, Hauth JC, Cassell GH. Association of post-cesarean delivery endometritis with colonization of the chorioamnion by Ureaplasma urealyticum. Obstet Gynecol. 1995 Apr;85(4):509-14. doi: 10.1016/0029-7844(94)00436-H.
Results Reference
background
PubMed Identifier
28697108
Citation
Harper LM, Kilgore M, Szychowski JM, Andrews WW, Tita ATN. Economic Evaluation of Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. Obstet Gynecol. 2017 Aug;130(2):328-334. doi: 10.1097/AOG.0000000000002129.
Results Reference
background
PubMed Identifier
18165392
Citation
Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
Results Reference
background
PubMed Identifier
21606770
Citation
ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
Results Reference
background
PubMed Identifier
29112658
Citation
Skeith AE, Niu B, Valent AM, Tuuli MG, Caughey AB. Adding Azithromycin to Cephalosporin for Cesarean Delivery Infection Prophylaxis: A Cost-Effectiveness Analysis. Obstet Gynecol. 2017 Dec;130(6):1279-1284. doi: 10.1097/AOG.0000000000002333.
Results Reference
background
PubMed Identifier
26656010
Citation
Smith C, Egunsola O, Choonara I, Kotecha S, Jacqz-Aigrain E, Sammons H. Use and safety of azithromycin in neonates: a systematic review. BMJ Open. 2015 Dec 9;5(12):e008194. doi: 10.1136/bmjopen-2015-008194.
Results Reference
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PubMed Identifier
25595580
Citation
Sutton AL, Acosta EP, Larson KB, Kerstner-Wood CD, Tita AT, Biggio JR. Perinatal pharmacokinetics of azithromycin for cesarean prophylaxis. Am J Obstet Gynecol. 2015 Jun;212(6):812.e1-6. doi: 10.1016/j.ajog.2015.01.015. Epub 2015 Jan 13.
Results Reference
background
PubMed Identifier
25350672
Citation
Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
Results Reference
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Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

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