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Prophylactic Antibiotics After Cesarean (PAC)

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ClinicalTrials.gov Identifier: NCT03187106
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Cephalexin Drug: Placebo Drug: Metronidazole Phase 1

Detailed Description:

The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics & Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.

In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.

All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Prophylactic Antibiotics After Cesarean
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 5, 2020
Estimated Study Completion Date : June 5, 2020


Arm Intervention/treatment
Experimental: Cephalexin and metronidazole
500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses
Drug: Cephalexin
Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

Drug: Metronidazole
Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses

Placebo Comparator: Placebo / standard of care
Placebo pills per oral every 8 hours for a total of 6 doses
Drug: Placebo
Placebo representing standard of care




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 6 weeks postpartum ]
    Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess


Secondary Outcome Measures :
  1. Maternal mortality [ Time Frame: 6 weeks (42 days) postpartum ]
    Maternal death

  2. Febrile morbidity [ Time Frame: 6 weeks (42 days) postpartum ]
    If the patient develops a measured temperate greater than or equal to 100.4 degrees Fahrenheit (or 38.0 degrees Celsius), she will have a postpartum fever.

  3. Postpartum antibiotic use [ Time Frame: 6 weeks (42 days) postpartum ]
    We will assess via chart review and direct patient inquiry whether or not antibiotics were taken by the patient for any purpose during the six weeks (42 days) immediately following delivery.

  4. Wound hematoma or seroma [ Time Frame: 6 weeks (42 days) postpartum ]
    Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma

  5. Use of resources [ Time Frame: 6 weeks (42 days) postpartum ]
    We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures

  6. Other adverse events [ Time Frame: 6 weeks postpartum ]
    Such as allergic reaction to study medications



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women >18 and <50 years
  • BMI >30kg/m2
  • Decision by clinical team to perform Cesarean section
  • Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)

Exclusion Criteria:

  • Subject unwilling or unable to provide consent
  • No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery
  • Fetal demise or major congenital anomaly
  • Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other
  • Diagnosis or suspicion of chorioamnionitis prior to randomization
  • Other planned post-operative antibiotic administration
  • High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)
  • Known allergy or contraindication to cephalosporins or metronidazole
  • Incarcerated individuals

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): NCT03187106


Contacts
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Contact: Maggie J Kuhlmann-Capek, MD 4097897784 makuhlma@utmb.edu
Contact: Antonio F Saad, MD 4097721571 afsaad@utmb.edu

Locations
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United States, Texas
St. David's North Austin Medical Center Recruiting
Austin, Texas, United States, 78758
Contact: Richard T Hale, PhD         
University of Texas Medical Branch John Sealy Hospital Recruiting
Galveston, Texas, United States, 77555
Contact: Maggie J Kuhlmann-Capek, MD    409-789-7784    makuhlma@utmb.edu   
Contact: Antonio F Saad, MD    4097721571    afsaad@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Antonio F Saad, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03187106     History of Changes
Other Study ID Numbers: 17-0035
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Metronidazole
Cephalexin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents