Trial Outcomes & Findings for Efficacy of Labor Epidurals for Postpartum Tubal Ligation (NCT NCT02564016)
NCT ID: NCT02564016
Last Updated: 2018-11-14
Results Overview
The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
one year
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
Capped Epidural
Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion.
|
Normal Saline Infusion
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
14
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Labor Epidurals for Postpartum Tubal Ligation
Baseline characteristics by cohort
| Measure |
Capped Epidural
n=22 Participants
Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion.
|
Normal Saline Infusion
n=14 Participants
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32 years
n=99 Participants
|
32 years
n=107 Participants
|
32 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: one yearThe goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.
Outcome measures
| Measure |
Capped Epidural
n=22 Participants
Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion.
|
Normal Saline Infusion
n=14 Participants
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
|
|---|---|---|
|
Number of Participants With Successful Epidural Reactivation
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: one yearOutcome measures
| Measure |
Capped Epidural
n=22 Participants
Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion.
|
Normal Saline Infusion
n=14 Participants
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
|
|---|---|---|
|
Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: one yearOutcome measures
| Measure |
Capped Epidural
n=22 Participants
Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion.
|
Normal Saline Infusion
n=14 Participants
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
|
|---|---|---|
|
Count of Participants Who Experienced Epidural Reactivation Failure
|
1 Participants
|
0 Participants
|
Adverse Events
Capped Epidural
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline Infusion
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
Laura L Roberts MD, Assistant Professor
Medical University of South Carolina
Phone: 843 792 2322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place