Cesarean DeliveryNCT00736580
Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery
A study testing Blunt tipped needle and Sharp needles in people with Cesarean Delivery and Glove Perforation, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery, Glove Perforation
- What is being tested?
- Blunt tipped needle and Sharp needles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age undergoing Cesarean Delivery
Who cannot join
- Patient less than 18 years of age.
- Patient not undergoing Cesarean Delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals
Morgantown, West Virginia, 26506
About this study
Official title: Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery
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.
- Conditions
- Cesarean Delivery, Glove Perforation
- Being tested
- Blunt tipped needle, Sharp needles
- Keywords
- Cesarean delivery, Surgical Needles, blunt-tip needles, surgical glove perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blunt tipped needleOther
The Cesarean delivery is performed using blunt tipped needles.
Sharp needlesOther
The cesarean is performed using standard sharp surgical suture needles.
| Study group | Role | What they receive |
|---|---|---|
| Blunt Needles | Active comparator | Cesarean Delivery Performed with Blunt-tipped surgical Needles Receives: Other: Blunt tipped needle |
| Sharp Needles | Placebo comparator | Cesarean delivery performed with sharp surgical needles. Receives: Other: Sharp needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Glove Perforation.
Direct measurement of the number of glove perforations listed by surgical case.
Measured: 1 week
Secondary outcomes (1)
Surgeon Satisfaction by Likert Scale.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stitely, West Virginia University
- Investigators
- Michael L Stitely, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736580
- Sponsor's protocol ID
- H-20783
- Status last verified
- Dec 2012
- First submitted
- 14 Aug 2008
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24294709
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glove Perforation When Using Blunt vs. Sharp Needles in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00736580
- Acronym / sponsor ID
- H-20783
- Conditions
- Cesarean Delivery, Glove Perforation
- Keywords
- Cesarean delivery, Surgical Needles, blunt-tip needles, surgical glove perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 24 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blunt Needles | Active comparator | Other: Blunt tipped needleCesarean Delivery Performed with Blunt-tipped surgical Needles |
| Sharp Needles | Placebo comparator | Other: Sharp needlesCesarean delivery performed with sharp surgical needles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at least 18 years of age undergoing Cesarean Delivery
Key exclusion criteria (2 listed)
- Patient less than 18 years of age.
- Patient not undergoing Cesarean Delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blunt tipped needleThe Cesarean delivery is performed using blunt tipped needles. | Other | Blunt Needles |
| Sharp needlesThe cesarean is performed using standard sharp surgical suture needles. | Other | Sharp Needles |
Primary outcome
Surgical Glove Perforation.
Time frame: 1 week
Direct measurement of the number of glove perforations listed by surgical case.
1 secondary outcome
Surgeon Satisfaction by Likert Scale.
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24294709Stitely 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Stitely, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blunt tipped needle and Sharp needles in people with Cesarean Delivery and Glove Perforation, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Glove Perforation. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013; AzTrials last refreshed its copy on 27 Oct 2026.