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Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT00736580
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : January 24, 2013
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Stitely, West Virginia University

Brief Summary:
This study is assessing whether there is a decrease in surgical glove punctures using blunt tipped needles compared with sharp needles for suturing during Cesarean Delivery.

Condition or disease Intervention/treatment Phase
Cesarean Delivery Glove Perforation Other: Blunt tipped needle Other: Sharp needles Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Blunt Needles
Cesarean Delivery Performed with Blunt-tipped surgical Needles
Other: Blunt tipped needle
The Cesarean delivery is performed using blunt tipped needles.
Placebo Comparator: Sharp Needles
Cesarean delivery performed with sharp surgical needles.
Other: Sharp needles
The cesarean is performed using standard sharp surgical suture needles.



Primary Outcome Measures :
  1. Surgical Glove Perforation. [ Time Frame: 1 week ]
    Direct measurement of the number of glove perforations listed by surgical case.


Secondary Outcome Measures :
  1. Surgeon Satisfaction by Likert Scale. [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at least 18 years of age undergoing Cesarean Delivery

Exclusion Criteria:

  • Patient less than 18 years of age.
  • Patient not undergoing Cesarean Delivery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736580


Locations
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Michael L Stitely, MD West Virginia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00736580     History of Changes
Other Study ID Numbers: H-20783
First Posted: August 18, 2008    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: December 2012

Keywords provided by Michael Stitely, West Virginia University:
Cesarean delivery
Surgical Needles
blunt-tip needles
surgical glove perforation