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Intrathecal Hydromorphone for Labor Analgesia (LITH)

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ClinicalTrials.gov Identifier: NCT02277782
Recruitment Status : Unknown
Verified January 2018 by Dominique Arce, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dominique Arce, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE October 24, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Effect on maternal temperature during labor [ Time Frame: 2 years ]
The primary outcome measure will be the incidence of maternal temperature increase, defined as an increase in maternal temperature by 1 degree celsius over the baseline temperature recorded prior to the onset of epidural analgesia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Effect on efficacy of labor analgesia [ Time Frame: 2 years ]
The secondary outcome measure will be the duration of intrathecal analgesia. Additional outcome measures include the quality of analgesia as recorded by the Visual Analogue Scale score and the need for additional top-ups within 90 min of epidural placement.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Hydromorphone for Labor Analgesia
Official Title  ICMJE Intrathecal Hydromorphone for Labor Analgesia
Brief Summary

The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will:

  1. Prolong the duration and improve the quality of analgesia in labor, and
  2. Decrease the incidence of epidural-associated temperature increase in labor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Drug: Hydromorphone
    Other Name: Dilaudid
  • Drug: Hyperbaric bupivacaine
  • Drug: Fentanyl
Study Arms  ICMJE
  • Active Comparator: No Hydromorphone
    1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
    Interventions:
    • Drug: Hyperbaric bupivacaine
    • Drug: Fentanyl
  • Experimental: Hydromorphone
    1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
    Interventions:
    • Drug: Hydromorphone
    • Drug: Hyperbaric bupivacaine
    • Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks).

Exclusion Criteria:

  • Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277782
Other Study ID Numbers  ICMJE 2014P002384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dominique Arce, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP