Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries

September 15, 2019 updated by: Tali Wajsfeld, RWJ Barnabas Health at Jersey City Medical Center

Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Jersey City Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: One-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once
Drug: Mefoxin 2g
Standard Prophylaxis
Other Names:
  • Cefoxitin
Experimental: Two-drug Prophylaxis
Mefoxin 2g IV, Piggyback, once and Azithromycin 500mg IV, Piggyback, once
Drug: Mefoxin 2g
Standard Prophylaxis
Other Names:
  • Cefoxitin
Drug: Azithromycin 500 mg
Additional IV Azithromycin 500 mg to Standard Prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks after delivery
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.
Up to 6 weeks after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Maternal Fever
Time Frame: Up to 6 weeks after delivery
Temperature equal or greater than 100.4F
Up to 6 weeks after delivery
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
Up to 6 weeks after delivery
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.
Up to 6 weeks after delivery
Rates of Serious Adverse Events
Time Frame: Up to 6 weeks after delivery
MICU admission, thromboembolic events, sepsis, maternal death
Up to 6 weeks after delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 6 weeks after delivery
Rates of Neonatal Readmission
Time Frame: Up to 6 weeks after delivery
Hospital readmission within 6 weeks of birth
Up to 6 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWJ Barnabas Health at Jersey City Medical Center

Investigators

  • Principal Investigator: Tali Wajsfeld, MD, RWJ Barnabas Health at Jersey City Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2019

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prophylaxis Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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