Increased Cefazolin During Cesarean Delivery in Obese Population

NCT02049944 | Completed Phase 4 Results

• 1 other identifier: 186-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophylactic dose, can then be compared to our pilot study assays in hopes of determining an optimal dosing for the obese and morbidly obese populations undergoing cesarean delivery. A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the obese and extremely obese populations. The purpose of this research study is to evaluate whether in increased dose of antibiotics given before cesarean delivery (3 grams of cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an effect on the levels of antibiotics in the tissues (a group of similar cells). This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index (BMI) of 30-40) and morbidly obese (BMI \>40) women to receive an increased dose of prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC. Researchers hope to enroll a total of 35 women overall.

Conditions

Obesity; Obesity, Morbid; Pregnancy; Infection; Cesarean Section

Keywords

Antibiotic Prophylaxis; Obesity; Obesity, Morbid; Pregnancy; Infection; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery

  Primary Objective: To assess the effects of increased prophylactic doses of Cefazolin in the obese and morbidly obese populations undergoing cesarean delivery. Effects will be defined as the ability to reach the minimal inhibitory concentrations for gram-positive and gram-negative organisms in adipose tissue and serum at time of skin incision and skin closure as defined by the Clinical and Laboratory Standards Institute

  Each participant is to be observed per routine operative and post-operative guidelines, inpatient for 3-4 days.

Study Arms (1)

Cefazolin

EXPERIMENTAL

All subjects undergoing elective term cesarean delivery will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision.

Drug: Cefazolin

Interventions

Cefazolin DRUG

Participants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line.

Also known as: Ancef

Cefazolin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at term (\>37 weeks) undergoing a cesarean delivery at Women's Pavilion at Miller Children's Hospital and University of California, Irvine.

You may not qualify if:

• pre-gestational diabetes
• chronic hypertension
• collagen vascular disease
• renal impairment
• multiple gestation
• contraindications to Cefazolin administration (known anaphylactic reaction to penicillin's or known cephalosporin allergy)
• any exposure to cephalosporins in one week prior to cesarean section
• need for emergent cesarean delivery or diagnosis of chorioamnionitis

Sponsors & Collaborators

• MemorialCare Health System: lead
• University of California, Irvine: collaborator

Study Sites (2)

MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Infections

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

Results Point of Contact

• Title: Dr. Morgan Swank
• Organization: Memorial Care

morganswankmd@gmail.com

5624808460

Study Officials

• Jennifer McNulty, MD

  MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center

  PRINCIPAL INVESTIGATOR

• Deborah A Wing, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Morgan Swank, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 30, 2014
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2020-12

Locations

US (2)