Study Stopped
Of 36 participants only 8 participants able to fully complete the study procedures. At this time, the study will be closed due to poor enrollment numbers.
Efficacy of Labor Epidurals for Postpartum Tubal Ligation
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedNovember 14, 2018
October 1, 2018
1.9 years
July 17, 2015
June 19, 2018
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
one year
Secondary Outcomes (2)
Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.
one year
Count of Participants Who Experienced Epidural Reactivation Failure
one year
Study Arms (2)
Capped Epidural
ACTIVE COMPARATORGroup 1 (control) will have the epidural catheter capped and left in place.
Normal Saline Infusion
EXPERIMENTALGroup 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Interventions
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Eligibility Criteria
You may qualify if:
- Pregnant women
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura L Roberts MD, Assistant Professor
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Roberts, MD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
September 30, 2015
Study Start
October 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 14, 2018
Results First Posted
November 14, 2018
Record last verified: 2018-10