MedDataX Logo

Trial Outcomes & Findings for Increased Cefazolin During Cesarean Delivery in Obese Population (NCT NCT02049944)

NCT ID: NCT02049944

Last Updated: 2021-02-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure
3g Cefazolin
Prospective cohort obese women receiving 3g prophylactic cefazolin 30-60 minutes prior to scheduled cesarean delivery
Overall Study
STARTED
30
Overall Study
Obese (BMI 30-40kg/m^2)
14
Overall Study
Extremely Obese (BMI >40kg/m^2)
14
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
3g Cefazolin
Prospective cohort obese women receiving 3g prophylactic cefazolin 30-60 minutes prior to scheduled cesarean delivery
Overall Study
Protocol Violation
2

Baseline Characteristics

these data were analyzed by BMI category, 14 obese and 14 extremely obese.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3g Cefazolin
n=28 Participants
3g IV cefazolin given 30-60 minutes prior to skin incision
Age, Categorical
<=18 years
0 Participants
n=28 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
n=28 Participants
Age, Categorical
>=65 years
0 Participants
n=28 Participants
Age, Continuous
31.5 years
n=28 Participants
Sex: Female, Male
Female
28 Participants
n=28 Participants
Sex: Female, Male
Male
0 Participants
n=28 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=28 Participants
Race (NIH/OMB)
Asian
2 Participants
n=28 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=28 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=28 Participants
Race (NIH/OMB)
White
5 Participants
n=28 Participants
Race (NIH/OMB)
More than one race
18 Participants
n=28 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=28 Participants
Region of Enrollment
United States
28 Participants
n=28 Participants
preoperative hemoglobin
12.0 g/dL
n=28 Participants
Average BMI
Obese, BMI 30-40kg/m^2
33.82 kg/m2
STANDARD_DEVIATION 2.92 • n=14 Participants • these data were analyzed by BMI category, 14 obese and 14 extremely obese.
Average BMI
Extremely Obese, BMI >40kg/m^2
45.03 kg/m2
STANDARD_DEVIATION 3.77 • n=14 Participants • these data were analyzed by BMI category, 14 obese and 14 extremely obese.

PRIMARY outcome

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

Population: participants were divided in BMI categories, 30-40kg/m2 and \>40kg/m2.

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

Outcome measures

Outcome measures
Measure
3g Cefazolin
n=28 Participants
Prospective cohort obese women receiving 3g prophylactic cefazolin 30-60 minutes prior to scheduled cesarean delivery
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery
BMI 30-40 3g
22.4 mg/g
Interval 20.3 to 34.4
Achievement of Minimal Inhibitory Concentrations Within Adipose and Serum Sampled at Time of Cesarean Delivery
BMI >40 3g
9.6 mg/g
Interval 7.6 to 15.8

Adverse Events

3g Cefazolin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Morgan Swank

Memorial Care

Phone: 5624808460

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place