NCT01755026

Brief Summary

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 21, 2013

Completed
Last Updated

August 21, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

June 29, 2011

Results QC Date

June 12, 2013

Last Update Submit

June 12, 2013

Conditions

Cesarean DeliveryWound InfectionObesity

Keywords

Cesarean DeliveryWound infectionObesityProphylactic antibiotics

Outcome Measures

Primary Outcomes (1)

  • Cefazolin Levels

    Cefazolin levels

    2 hours

Study Arms (2)

2 gram dose of cefazolin

ACTIVE COMPARATOR

2 gram dose of pre-operative cefazolin

Drug: cefazolin

4 gram Dose

EXPERIMENTAL

4 gram dose of pre-operative prophylaxis

Drug: cefazolin

Interventions

cefazolinDRUG

2 gram dose for pre-operative prophylaxis

Also known as: Ancef
2 gram dose of cefazolin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or above
  • Body mass index (BMI) of 35 or greater at the time of the first obstetric clinic visit
  • Undergoing cesarean delivery

You may not qualify if:

  • BMI less than 35.
  • Not undergoing Cesarean delivery.
  • Age less than 18 years.
  • Pre-existing infection.
  • Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
  • Cesarean delivery being performed under emergent circumstances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Wound InfectionObesity

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

InfectionsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
michael stitely
Organization
west virginia university
mstitely@hsc.wvu.edu
304-293-5631

Study Officials

  • William H Holls, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

  • Michael L Stitely, MD

    West Virginia University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

June 29, 2011

First Posted

December 21, 2012

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

November 1, 2012

Last Updated

August 21, 2013

Results First Posted

August 21, 2013

Record last verified: 2013-06

Locations

US(1)