Prophylactic Antibiotics After Cesarean

NCT ID: NCT03187106

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-07-21

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Cephalexin

Intervention Type: DRUG

Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

Metronidazole

Intervention Type: DRUG

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

Placebo / standard of care

Placebo pills per oral every 8 hours for a total of 6 doses

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo representing standard of care

Interventions

Cephalexin

Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

Intervention Type: DRUG

Placebo

Placebo representing standard of care

Intervention Type: DRUG

Metronidazole

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio F Saad, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

St. David's North Austin Medical Center

Austin, Texas, United States

University of Texas Medical Branch John Sealy Hospital

Galveston, Texas, United States

Countries

United States

References

Saad AF, Goldman B, Spencer N, Kuhlmann M, McDonnold M, Saade GR. Prophylactic Oral Cephalexin and Metronidazole Compared With Placebo After Cesarean Delivery to Reduce Infection Complications in Women With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2025 May 22;146(1):113-120. doi: 10.1097/AOG.0000000000005936.

Reference Type: DERIVED

PMID: 40403315 (View on PubMed)

Other Identifiers

17-0035

Identifier Type: -

Identifier Source: org_study_id