Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
NCT ID: NCT04017442
Last Updated: 2024-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2019-10-19
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Morphine
2mg preservative free morphine
Preservative Free Morphine
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Saline
4 mL preservative free saline
Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Interventions
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Preservative Free Morphine
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient refusal
* Allergy to morphine
* Patients with chronic pain syndromes
18 Years
FEMALE
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Daniel Katz
Associate Professor
Principal Investigators
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Daniel Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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References
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Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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GCO 18-2789
Identifier Type: -
Identifier Source: org_study_id
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