PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN

NCT01810354 | Completed

• 1 other identifier: 13-0004
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin. Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery. Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis. While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.

Conditions

Infection Prevention

Keywords

Cefazolin; Tissue concentration; infection; cesarean section; obese

Outcome Measures

Primary Outcomes (1)

• Adipose tissue concentration of cefazolin

  Two separate two gram samples of adipose tissue will be removed from the subcutaneous tissue. The first sample will be removed after skin incision, yet prior to fascial incision. The second sample will be collected after fascial closure, yet prior to skin closure.

  At the start of the cesarean section and at the end of the cesarean section

Secondary Outcomes (1)

• Serum cefazolin concentrations

  After antibiotic infusion, at the start of the cesarean section, and at the end of the cesarean section

Other Outcomes (1)

• Infectious morbidity

  Participants will be followed for a duration of 6-8 weeks after the cesarean section

Study Arms (2)

Two grams cefazolin

EXPERIMENTAL

Two grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section.

Drug: Cefazolin

Three grams cefazolin

ACTIVE COMPARATOR

Three grams of cefazolin will be given by intravenous bolus zero to 60 minutes prior to the start of the cesarean section.

Drug: Cefazolin

Interventions

Cefazolin DRUG

Three grams cefazolin; Two grams cefazolin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese - body mass index (BMI) calculated as weight (kg)/ \[height (m2)\]greater than or equal to 30 as determined at their first prenatal visit
• Gestational age of 37 0/7 weeks and greater
• Singleton Pregnancy
• Non-emergent cesarean section

You may not qualify if:

• Known cephalosporin allergy
• Severe allergy to penicillin making cephalosporin use a contraindication
• Exposure to antibiotics in the preceding 7 days
• Need for emergent cesarean section
• Multiple gestations
• Suspected chorioamnionitis
• Pre-gestational diabetes
• Chronic hypertension with evidence of end organ damage

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Maggio L, Nicolau DP, DaCosta M, Rouse DJ, Hughes BL. Cefazolin prophylaxis in obese women undergoing cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1205-1210. doi: 10.1097/AOG.0000000000000789.

  PMID: 25932849 DERIVED

MeSH Terms

Conditions

Infections; Obesity

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lindsay Maggio, MD

  Women & Infant's Hospital

  PRINCIPAL INVESTIGATOR

• Brenna Anderson, MD

  Women & Infants Hospital

  STUDY DIRECTOR

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: Maternal-Fetal Medicine Fellow

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 13, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)