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Anti-infective

Extended Antibiotics for Preventing Infections After Cesarean Delivery (SSI Trial)

N/A
Waitlist Available
Led By Carri Warshak, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age 13 or older
Delivery via cesarean section
Must not have
non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 40 Other Conditions
All Individual Drugs Already Approved

Summary

This trial will test if a longer course of antibiotics can prevent infection in obese women who have C-sections.

Who is the study for?
This trial is for English-speaking individuals aged 13 or older with a BMI over 30 who are undergoing cesarean delivery. They must consent to participate and not have any known immunodeficiency syndromes or allergies to cephalosporins or metronidazole.
What is being tested?
The study is testing if taking antibiotics (cephalexin & metronidazole) for a prolonged period of 48 hours after surgery can prevent infections at the surgical site in obese patients, compared to just using a placebo.
What are the potential side effects?
Possible side effects from cephalexin & metronidazole may include stomach upset, diarrhea, nausea, vomiting, rash, and rarely more serious reactions like severe allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 13 years old or older.
Select...
I delivered my baby through a cesarean section.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 40 Other Conditions
This treatment demonstrated efficacy for 40 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cephalexin and metronidazoleExperimental Treatment1 Intervention
500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses
Group II: Placebo/standard of carePlacebo Group1 Intervention
Placebo pills per oral every 8 hours for total of 6 doses

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,273 Total Patients Enrolled
Carri Warshak, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

Cephalexin & Metronidazole (Anti-infective) Clinical Trial Eligibility Overview. Trial Name: NCT01194115 — N/A
Surgical Site Infection Research Study Groups: Cephalexin and metronidazole, Placebo/standard of care
Surgical Site Infection Clinical Trial 2023: Cephalexin & Metronidazole Highlights & Side Effects. Trial Name: NCT01194115 — N/A
Cephalexin & Metronidazole (Anti-infective) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01194115 — N/A
~31 spots leftby Jan 2026
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