Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Pregnant women - 18 to 45 years of age - Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia - Postpartum tubal ligation following delivery - American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3 Exclusion Criteria: - Critically Ill Patients (patients admitted to the ICU) - Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit) - Cesarean delivery - Punctured dura - Patients enrolled in other epidural research studies


Study is Available At:


Original ID:

Pro00033454


NCT ID:

NCT02564016


Secondary ID:


Study Acronym:


Brief Title:

Efficacy of Labor Epidurals for Postpartum Tubal Ligation


Official Title:

Efficacy of Labor Epidurals for Postpartum Tubal Ligation: Effect of Postpartum Epidural Saline Infusion on the Reactivation of Labor Epidurals for Postpartum Tubal Ligation Following Vaginal Delivery


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Of 36 participants only 8 participants able


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Laura Roberts, MD
Principal Investigator
Medical University of South Carolina

Study Dates

Start Date:October 2014
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:September 2016
Primary Completion Type:Actual
Verification Date:September 2016
Last Changed Date:January 10, 2018
First Received Date:July 17, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Time from delivery to tubal ligation
Time Frame:one year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Association of height and weight on epidural reactivation rate success
Time Frame:one year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Successful epidural reactivation rate
Time Frame:one year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Normal Saline Infusion
Description:Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Arm Name:Normal Saline Infusion
Other Name:0.9% Sodium Chloride
Intervention Type:Other
Name:Capped Epidural
Description:epidural will be capped with no saline infusion.
Arm Name:Capped Epidural

Study Arms

Study Arm Type:Active Comparator
Arm Name:Capped Epidural
Description:Group 1 (control) will have the epidural catheter capped and left in place.
Study Arm Type:Experimental
Arm Name:Normal Saline Infusion
Description:Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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