Pregnancy
Conditions
Keywords
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.
Interventions
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on maternal temperature during labor | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on efficacy of labor analgesia | 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. |
Countries
United States
Outcome results
None listed