Intrathecal Hydromorphone for Labor Analgesia

Pregnancy Clinical Trial

— LITH  

Official title:

Intrathecal Hydromorphone for Labor Analgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02277782
• Other study ID #: 2014P002384
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Hydromorphone

• Hyperbaric bupivacaine

• Fentanyl

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on maternal temperature during labor	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.	2 years
Secondary	Effect on efficacy of labor analgesia	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.	2 years