Comparison of Multiport Versus Uniport Soft-tip Catheter for Administering Epidural Pain Relief During Labor and Delivery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01861821
First received: June 1, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare the effectiveness of a Perifix FX soft-tip multiport catheter with a Perifix FX soft-tip uniport catheter at delivering analgesia during labor and delivery.The uniport catheter has a single hole at the tip of the catheter, while the multiport catheter has a closed tip and three lateral holes.


Condition Intervention
Pain During Labor and Delivery
Device: Perifix soft-tip uniport catheter
Device: Perifix soft-tip multiport

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a New Multiport Versus Uniport Soft-tip Catheter for Epidural Analgesia During Labor and Delivery

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Incidence of complete analgesia within 30 minutes of initiating epidural analgesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of problems inserting catheter [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Incidence of catheter breakage during removal. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Perifix soft-tip uniport catheter
Soft-tip uniport catheter used to deliver epidural pain medicine. "Uniport" is the key element.
Device: Perifix soft-tip uniport catheter
Active Comparator: Perifix soft-tip multiport catheter
Soft-tip multiport catheter used to deliver epidural pain medicine. "Multiport" is the key element.
Device: Perifix soft-tip multiport

Detailed Description:

The primary outcome being studied is whether complete analgesia is achieved within 30 minutes of delivery of the loading dose. Other outcomes that will be studied include problems with insertion of the catheters and problems with removal of the catheters. Both of the catheters that are being studied are FDA-approved and in current use.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman in either spontaneous or induced labor who desires pain relief from an epidural
  • Estimated gestational age at least 37 weeks
  • Singleton gestation
  • Cephalic presentation

Exclusion Criteria:

  • Prior cesarean section
  • Fetal abnormality
  • BMI greater than 45
  • Chronic analgesic medication
  • Local anesthetic allergy
  • Subject with a coagulopathy or who is anticoagulated
  • Infection at epidural site
  • Generalized sepsis
  • Spinal deformity other than minor scoliosis
  • Subject with uncontrolled cerebral, cardiac, pulmonary, GI, hepatic, renal, endocrine, metabolic or hematologic condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861821

Locations
United States, Texas
Baylor All Saints Medical Center
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Baylor Research Institute
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: John Philip, MD Baylor Health Care Systems
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01861821     History of Changes
Other Study ID Numbers: 010-158
Study First Received: June 1, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Epidural
Labor and Delivery
Uniport Catheter
Multiport Catheter

ClinicalTrials.gov processed this record on October 29, 2014