An interventional study of Normal Saline Infusion and Capped Epidural in Pregnancy, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL.
If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital.
The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.
Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1 (control) will have the epidural catheter capped and left in place.
Other: Capped Epidural
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Drug: Normal Saline Infusion
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Also known as: 0.9% Sodium Chloride
epidural will be capped with no saline infusion.
Number of Participants With Successful Epidural Reactivation
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.
Time frame: one year
Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.
Time frame: one year
Count of Participants Who Experienced Epidural Reactivation Failure
Time frame: one year
| Milestone | Capped Epidural | Normal Saline Infusion |
|---|---|---|
| Started | 22 | 14 |
| Completed | 4 | 4 |
| Not completed | 18 | 10 |
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.
| participants | Capped Epidural | Normal Saline Infusion |
|---|---|---|
| Number of Participants With Successful Epidural Reactivation | 3 | 4 |
| Participants | Capped Epidural | Normal Saline Infusion |
|---|---|---|
| Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery. | 4 | 4 |
| Participants | Capped Epidural | Normal Saline Infusion |
|---|---|---|
| Count of Participants Who Experienced Epidural Reactivation Failure | 1 | 0 |
Collected over The timeframe is approximately 1-4 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capped Epidural | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Normal Saline Infusion | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Capped Epidural | Normal Saline Infusion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 14 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Capped Epidural | Normal Saline Infusion | Total |
|---|---|---|---|
| Mean | 32 (21 to 42) | 32 (22 to 41) | 32 (21 to 42) |
| Sex: Female, Male(Participants) | Capped Epidural | Normal Saline Infusion | Total |
|---|---|---|---|
| Female | 22 | 14 | 36 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Capped Epidural | Normal Saline Infusion | Total |
|---|---|---|---|
| United States | 22 | 14 | 36 |
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina