Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

NCT ID: NCT00736580

Last Updated: 2013-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Delivery Glove Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Blunt Needles

Cesarean Delivery Performed with Blunt-tipped surgical Needles

Group Type ACTIVE_COMPARATOR

Blunt tipped needle

Intervention Type OTHER

The Cesarean delivery is performed using blunt tipped needles.

Sharp Needles

Cesarean delivery performed with sharp surgical needles.

Group Type PLACEBO_COMPARATOR

Sharp needles

Intervention Type OTHER

The cesarean is performed using standard sharp surgical suture needles.

Interventions

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Blunt tipped needle

The Cesarean delivery is performed using blunt tipped needles.

Intervention Type OTHER

Sharp needles

The cesarean is performed using standard sharp surgical suture needles.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Michael Stitely

Adjunct Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Stitely, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Stitely ML, Close J, Ferda A, Mehra S, Malson B, Hembree W. Glove perforations with blunt versus sharp surgical needles in caesarean delivery: a randomized trial. W V Med J. 2013 Sep-Oct;109(5):32-6.

Reference Type DERIVED
PMID: 24294709 (View on PubMed)

Other Identifiers

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H-20783

Identifier Type: -

Identifier Source: org_study_id

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