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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blunt Needles | Active Comparator | Cesarean Delivery Performed with Blunt-tipped surgical Needles |
|
| Sharp Needles | Placebo Comparator | Cesarean delivery performed with sharp surgical needles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blunt tipped needle | Other | The Cesarean delivery is performed using blunt tipped needles. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Glove Perforation. | Direct measurement of the number of glove perforations listed by surgical case. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Satisfaction by Likert Scale. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Stitely, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Hospitals | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24294709 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blunt Needles | Cesarean Delivery Performed with Blunt-tipped surgical Needles |
| FG001 | Sharp Needles | Cesarean delivery performed with sharp surgical needles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blunt Needles | Cesarean Delivery Performed with Blunt-tipped surgical Needles |
| BG001 | Sharp Needles | Cesarean delivery performed with sharp surgical needles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgical Glove Perforation. | Direct measurement of the number of glove perforations listed by surgical case. | Posted | Number | Cases with a glove puncture | 1 week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blunt Needles | Cesarean Delivery Performed with Blunt-tipped surgical Needles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Stitely, MD | West Virginia University | 304-293-1566 | mstitely@hsc.wvu.edu |
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| Sharp needles |
| Other |
The cesarean is performed using standard sharp surgical suture needles. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Surgeon Satisfaction by Likert Scale. | Not Posted | 1 week |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Sharp Needles | Cesarean delivery performed with sharp surgical needles. | 0 | 123 | 0 | 123 |
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