Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT03187106
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03187106
Study Brief:
Protocol Section:
NCT03187106