Increased Cefazolin During Cesarean Delivery in Obese Population

Completed · Phase 4

Conditions studied: Obesity, Obesity, Morbid, Pregnancy, Infection; Cesarean Section

In brief

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.

Key facts

Study ID

NCT02049944

Run by

MemorialCare Health System

People needed

30

Starts

2013-08-01

Expected to finish

2014-12-01

Last updated by the study team

2021-02-02

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• MemorialCare Center for Women at Miller Children's Hospital Long Beach and Long Beach Memorial Medical Center — Long Beach, California, United States
• University of California, Irvine — Orange, California, United States

Full record on ClinicalTrials.gov

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