Trial Outcomes & Findings for Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery (NCT NCT01755026)

Last Updated: 2013-08-21

Results Overview

Cefazolin levels

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

2 hours

Results posted on

2013-08-21

Participant milestones
Measure	4 Gram Dose 4 gram dose of pre-operative prophylaxis	2 Gram Dose of Cefazolin 2 gram dose of pre-operative cefazolin
Overall Study STARTED	11	12
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal
Measure	4 Gram Dose 4 gram dose of pre-operative prophylaxis	2 Gram Dose of Cefazolin 2 gram dose of pre-operative cefazolin
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	1

Serum and Tissue Cefazolin Concentrations in Patients Undergoing Cesarean Delivery

Baseline characteristics by cohort
Measure	4 Gram Dose n=11 Participants 4 gram dose of pre-operative prophylaxis	2 Gram Dose of Cefazolin n=12 Participants 2 gram dose of pre-operative cefazolin	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	30.33 years STANDARD_DEVIATION 4.64 • n=5 Participants	31.09 years STANDARD_DEVIATION 6.46 • n=7 Participants	31 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

Timeframe: 2 hours

Cefazolin levels

Outcome measures
Measure	2 Gram Dose of Cefazolin n=9 Participants 2 gram dose of pre-operative cefazolin	4 Gram Dose n=11 Participants 4 gram dose of pre-operative prophylaxis
Cefazolin Levels Myometrial levels	67.18 mcg/mL Standard Error 13.89	146.22 mcg/mL Standard Error 60.99
Cefazolin Levels Umbilical cord blood concentrations	25.01 mcg/mL Standard Error 12.03	82.23 mcg/mL Standard Error 43.03
Cefazolin Levels Subcutaneous tissue-opening	18.36 mcg/mL Standard Error 6.68	40.11 mcg/mL Standard Error 24.1
Cefazolin Levels Subcutaneous tissue-closing	21.73 mcg/mL Standard Error 16.02	34.89 mcg/mL Standard Error 17.42
Cefazolin Levels Plasma concentration at incision	155.45 mcg/mL Standard Error 50.97	346.16 mcg/mL Standard Error 166.01
Cefazolin Levels Plasma concentration at closure	83.49 mcg/mL Standard Error 34.97	150.12 mcg/mL Standard Error 55.54

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	4 Gram Dose n=11 participants at risk 4 gram dose of pre-operative prophylaxis	2 Gram Dose of Cefazolin n=12 participants at risk 2 gram dose of pre-operative cefazolin
Skin and subcutaneous tissue disorders Allergy	9.1% 1/11 • Number of events 1	0.00% 0/12

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