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NCT01598506 · ClinicalTrials.gov registry record · Phase 2
Intrathecal Hydromorphone for Labor Analgesia
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01598506 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 22 participants.
The verdict
NCT01598506, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. After the intrathecal injection is given and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, fetal heart rate, and any side effects will also be assessed.
Interventions
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01598506
The ClinicalTrials.gov registry entry for NCT01598506 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone is the first listed.
NCT01598506 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01598506 about?
NCT01598506 is a clinical study titled "Intrathecal Hydromorphone for Labor Analgesia". This study will investigate the dose of hydromorphone which will relieve the pain of women in labor when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of le...
What is the current status of trial NCT01598506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-09. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01598506?
The interventions under investigation include: Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT01598506?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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