- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04017442
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
September 20, 2023 updated by: Daniel Katz, Icahn School of Medicine at Mount Sinai
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo.
Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained.
After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal.
The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints.
The study will end at the 6 week postpartum visit with the patient's obstetrician.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pregnant women in labor
Exclusion Criteria:
- Not a candidate for neuraxial anesthesia
- Patient refusal
- Allergy to morphine
- Patients with chronic pain syndromes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Morphine
2mg preservative free morphine
|
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
|
Placebo Comparator: Saline
4 mL preservative free saline
|
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption
Time Frame: 24 hours
|
Quantity of opioid used in 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score
Time Frame: up to 24 hours
|
Pain Score: Likert full scale 1-10, with higher score indicating more pain
|
up to 24 hours
|
Obstetric Quality of Recovery Score (OBSQ10)
Time Frame: 24 hours
|
OBSQ10 total score 0-100, with higher score indicating better health status
|
24 hours
|
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: up to 6 weeks
|
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30.
Higher score indicates more depressed symptoms.
|
up to 6 weeks
|
Number of participants with breast feeding success
Time Frame: 1 week
|
Participants will respond yes/no as to their breast feeding success and continuation
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2019
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depressive Disorder
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Depression
- Depression, Postpartum
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Morphine
Other Study ID Numbers
- GCO 18-2789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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