Trial Outcomes & Findings for Comparison of Loss of Resistance Techniques (NCT NCT00638274)
NCT ID: NCT00638274
Last Updated: 2018-11-09
Results Overview
Number of participants that had successful spinal labor analgesia in each group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
356 participants
Primary outcome timeframe
24 hours
Results posted on
2018-11-09
Participant Flow
Participant milestones
| Measure |
1-AIR
Air 3 ml used to identify epidural space
Air: 3 mls used for identifying epidural space
|
2-SALINE
Saline 3 ml used to identify epidural space
Saline: 3 mls of saline used to identify epidural space
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
177
|
|
Overall Study
COMPLETED
|
173
|
172
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Loss of Resistance Techniques
Baseline characteristics by cohort
| Measure |
1-AIR
n=173 Participants
Air 3 ml used to identify epidural space
Air: 3 mls used for identifying epidural space
|
2-SALINE
n=172 Participants
Saline 3 ml used to identify epidural space
Saline: 3 mls of saline used to identify epidural space
|
Total
n=345 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
|
173 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
345 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
|
173 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
345 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
|
173 participants
n=5 Participants
|
172 participants
n=7 Participants
|
345 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumber of participants that had successful spinal labor analgesia in each group.
Outcome measures
| Measure |
1-AIR
n=173 Participants
Air 3 ml used to identify epidural space
Air: 3 mls used for identifying epidural space
|
2-SALINE
n=172 Participants
Saline 3 ml used to identify epidural space
Saline: 3 mls of saline used to identify epidural space
|
|---|---|---|
|
Success of Spinal Labor Analgesia From Combined Spinal Epidural
|
163 Participants
|
161 Participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.
Outcome measures
| Measure |
1-AIR
n=173 Participants
Air 3 ml used to identify epidural space
Air: 3 mls used for identifying epidural space
|
2-SALINE
n=172 Participants
Saline 3 ml used to identify epidural space
Saline: 3 mls of saline used to identify epidural space
|
|---|---|---|
|
Number of Participants With Failed Epidural Catheters
|
5 Participants
|
9 Participants
|
Adverse Events
1-AIR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2-SALINE
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
Peter H. Pan, MD
Wake Forest University School of Medicine
Phone: 336-718-82748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place