An interventional study of Hydromorphone and Hyperbaric bupivacaine in Pregnancy, sponsored by Brigham and Women's Hospital. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention
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:
Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1.7 mg bupivacaine + 17 mcg fentanyl + 0.05 ml of 0.9% normal saline.
Drug: Hyperbaric bupivacaine · Drug: Fentanyl
1.7 mg bupivacaine + 17 mcg fentanyl + 50 mcg preservative-free hydromorphone (0.05 ml)
Drug: Hydromorphone · Drug: Hyperbaric bupivacaine · Drug: Fentanyl
Also known as: Dilaudid
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.
Time frame: 2 years
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.
Time frame: 2 years
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital