Prophylactic Antibiotics After Cesarean (PACT)
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cephalexin
Placebo
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Site Infection
Eligibility 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
Sites / Locations
- St. David's North Austin Medical Center
- University of Texas Medical Branch John Sealy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cephalexin and metronidazole
Placebo / standard of care
Arm Description
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
Placebo pills per oral every 8 hours for a total of 6 doses
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Maternal mortality
Maternal death
Febrile morbidity
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.
Postpartum antibiotic use
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.
Wound hematoma or seroma
Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma
Use of resources
We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures
Other adverse events
Such as allergic reaction to study medications
Full Information
NCT ID
NCT03187106
First Posted
June 12, 2017
Last Updated
August 15, 2023
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT03187106
Brief Title
Prophylactic Antibiotics After Cesarean
Acronym
PACT
Official Title
Prophylactic Antibiotics After Cesarean
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
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.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cephalexin and metronidazole
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo / standard of care
Arm Type
Placebo Comparator
Arm Description
Placebo pills per oral every 8 hours for a total of 6 doses
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Intervention Description
Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo representing standard of care
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Maternal mortality
Description
Maternal death
Time Frame
6 weeks (42 days) postpartum
Title
Febrile morbidity
Description
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.
Time Frame
6 weeks (42 days) postpartum
Title
Postpartum antibiotic use
Description
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.
Time Frame
6 weeks (42 days) postpartum
Title
Wound hematoma or seroma
Description
Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma
Time Frame
6 weeks (42 days) postpartum
Title
Use of resources
Description
We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures
Time Frame
6 weeks (42 days) postpartum
Title
Other adverse events
Description
Such as allergic reaction to study medications
Time Frame
6 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio F Saad, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's North Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Texas Medical Branch John Sealy Hospital
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prophylactic Antibiotics After Cesarean
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