Trial Outcomes & Findings for Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery (NCT NCT00736580)

Results Overview

Direct measurement of the number of glove perforations listed by surgical case.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

240 participants

Primary outcome timeframe

1 week

Results posted on

2013-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Blunt Needles Cesarean Delivery Performed with Blunt-tipped surgical Needles	Sharp Needles Cesarean delivery performed with sharp surgical needles.
Overall Study STARTED	117	123
Overall Study COMPLETED	117	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blunt Needles n=117 Participants Cesarean Delivery Performed with Blunt-tipped surgical Needles	Sharp Needles n=123 Participants Cesarean delivery performed with sharp surgical needles.	Total n=240 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	117 Participants n=5 Participants	123 Participants n=7 Participants	240 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	123 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	117 participants n=5 Participants	123 participants n=7 Participants	240 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Direct measurement of the number of glove perforations listed by surgical case.

Outcome measures

Outcome measures
Measure	Blunt Needles n=117 Participants Cesarean Delivery Performed with Blunt-tipped surgical Needles	Sharp Needles n=123 Participants Cesarean delivery performed with sharp surgical needles.
Surgical Glove Perforation.	30 Cases with a glove puncture	30 Cases with a glove puncture

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Outcome data not reported

Adverse Events

Blunt Needles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sharp Needles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Stitely, MD

West Virginia University

Phone: 304-293-1566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place