This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

This study has been completed.
Information provided by (Responsible Party):
Michael Stitely, West Virginia University Identifier:
First received: August 14, 2008
Last updated: December 18, 2012
Last verified: December 2012
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 Intervention
Cesarean Delivery Glove Perforation Other: Blunt tipped needle Other: Sharp needles

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Michael Stitely, West Virginia University:

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

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

Enrollment: 240
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00736580

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Stitely, Adjunct Associate Professor, West Virginia University Identifier: NCT00736580     History of Changes
Other Study ID Numbers: H-20783
Study First Received: August 14, 2008
Results First Received: December 18, 2012
Last Updated: December 18, 2012

Keywords provided by Michael Stitely, West Virginia University:
Cesarean delivery
Surgical Needles
blunt-tip needles
surgical glove perforation processed this record on September 21, 2017