Trial Outcomes & Findings for Intrapartum Epidural Catheter Displacement: Dressing Methods (NCT NCT03574441)
NCT ID: NCT03574441
Last Updated: 2019-07-30
Results Overview
Percentage of participants for whom catheter migration was observed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
24 hours. The time from insertion to removal of catheter
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
TegadermTM Only
Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
|
Dressing With TegadermTM Plus Steri-StripTM Bands
Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
|
Dressing With TegadermTM Plus Catheter Support Pad.
Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
30
|
|
Overall Study
COMPLETED
|
31
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intrapartum Epidural Catheter Displacement: Dressing Methods
Baseline characteristics by cohort
| Measure |
TegadermTM Only
n=31 Participants
Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
|
Dressing With TegadermTM Plus Steri-StripTM Bands
n=30 Participants
Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
|
Dressing With TegadermTM Plus Catheter Support Pad.
n=30 Participants
Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
91 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
25 years
n=93 Participants
|
24 years
n=4 Participants
|
25 years
n=27 Participants
|
24 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
91 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
30 participants
n=4 Participants
|
30 participants
n=27 Participants
|
91 participants
n=483 Participants
|
|
Gestational age
|
36 Weeks
n=93 Participants
|
37 Weeks
n=4 Participants
|
37 Weeks
n=27 Participants
|
36 Weeks
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 hours. The time from insertion to removal of catheterPercentage of participants for whom catheter migration was observed
Outcome measures
| Measure |
TegadermTM Only
n=31 Participants
Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
|
Dressing With TegadermTM Plus Steri-StripTM Bands
n=30 Participants
Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
|
Dressing With TegadermTM Plus Catheter Support Pad.
n=30 Participants
Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
|
|---|---|---|---|
|
Epidural Catheter Migration
|
44 percentage patients catheter migration
|
25 percentage patients catheter migration
|
17 percentage patients catheter migration
|
SECONDARY outcome
Timeframe: 24 hours. The time from insertion to removal of catheter due to failureFrequency of epidural catheter replacement due to analgesic failure among the catheters in each arm
Outcome measures
| Measure |
TegadermTM Only
n=31 Participants
Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
|
Dressing With TegadermTM Plus Steri-StripTM Bands
n=30 Participants
Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
|
Dressing With TegadermTM Plus Catheter Support Pad.
n=30 Participants
Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
|
|---|---|---|---|
|
Rate of Epidural Catheter Replacement
|
3.2 percentage of catheters
|
3.3 percentage of catheters
|
3.3 percentage of catheters
|
Adverse Events
TegadermTM Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dressing With TegadermTM Plus Steri-StripTM Bands
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dressing With TegadermTM Plus Catheter Support Pad.
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place