NCT01194115

Brief Summary

The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

September 1, 2010

Last Update Submit

November 10, 2011

Conditions

Surgical Site Infection in Obese Women Undergoing C-section

Keywords

surgical site infectionobesitypregnancycesarean sectioncesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    6weeks post partum

Secondary Outcomes (1)

  • Febrile morbidity; Urinary tract infection; Endometritis

    6 weeks post partum

Study Arms (2)

Cephalexin and metronidazole

EXPERIMENTAL

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

Drug: cephalexin & metronidazole

Placebo/standard of care

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

cephalexin & metronidazoleDRUG

cephalexin at 500 mg per oral every 8 hours for a total of 6 doses

Also known as: Keflex & Flagyl
Cephalexin and metronidazole
placeboDRUG

placebo representing standard of care

Placebo/standard of care

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30kg/m\*2
  • Delivery via cesarean section
  • consent to participate
  • age 13 or older

You may not qualify if:

  • known immunodeficiency syndromes
  • non-English speaking
  • known allergy to cephalosporins or metronidazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Univeristy Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (6)

  • Hofmeyr GJ, Smaill FM. WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000933. doi: 10.1002/14651858.CD000933.pub2.

    PMID: 20091509BACKGROUND

  • Meyer NL, Hosier KV, Scott K, Lipscomb GH. Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5. doi: 10.1097/01.SMJ.0000060570.51934.14.

    PMID: 14570343BACKGROUND

  • Robinson HE, O'Connell CM, Joseph KS, McLeod NL. Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64. doi: 10.1097/01.AOG.0000188387.88032.41.

    PMID: 16319263BACKGROUND

  • Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M. Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.

    PMID: 6535654BACKGROUND

  • Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW. Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.

    PMID: 18771992BACKGROUND

  • Valent AM, DeArmond C, Houston JM, Reddy S, Masters HR, Gold A, Boldt M, DeFranco E, Evans AT, Warshak CR. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1026-1034. doi: 10.1001/jama.2017.10567.

    PMID: 28975304DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionObesity

Interventions

CephalexinMetronidazole

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Carri Warshak, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

US(1)