Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00736580|
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : January 24, 2013
Last Update Posted : January 24, 2013
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Surgical Glove Perforation. [ Time Frame: 1 week ]Direct measurement of the number of glove perforations listed by surgical case.
- Surgeon Satisfaction by Likert Scale. [ Time Frame: 1 week ]
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
|United States, West Virginia|
|West Virginia University Hospitals|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Michael L Stitely, MD||West Virginia University|