Clinical trial
Prophylactic Antibiotics After Cesarean
Name
17-0035
Description
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.
Trial arms
Trial start
2017-08-01
Estimated PCD
2023-07-21
Trial end
2023-07-21
Status
Completed
Phase
Early phase I
Treatment
Cephalexin
Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
Arms:
Cephalexin and metronidazole
Placebo
Placebo representing standard of care
Arms:
Placebo / standard of care
Metronidazole
Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
Arms:
Cephalexin and metronidazole
Size
321
Primary endpoint
Surgical site infection
6 weeks postpartum
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 321, 'type': 'ACTUAL'}}
Updated at
2023-08-16
1 organization
2 products
1 drug
1 indication
Organization
University of Texas Medical BranchProduct
CephalexinIndication
SSIsDrug
VarlilumabProduct
Metronidazole