Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

Cesarean Delivery Clinical Trial

Official title:

Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736580
• Other study ID #: H-20783
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: December 18, 2012
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2012
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Delivery
• Glove Perforation

Intervention

Other:
• Blunt tipped needle
The Cesarean delivery is performed using blunt tipped needles.
• Sharp needles
The cesarean is performed using standard sharp surgical suture needles.

Locations

Country	Name	City	State
United States	West Virginia University Hospitals	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Glove Perforation.	Direct measurement of the number of glove perforations listed by surgical case.	1 week	No
Secondary	Surgeon Satisfaction by Likert Scale.		1 week	No