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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT04017442
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Katz, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postpartum Pain Postpartum Depression Opioid Consumption Drug: Preservative Free Morphine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, prospective, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The only individual that will know to which group the patient was assigned is the individual on the study team who is drawing up the medication. This individual will have no other role in the assessment or evaluation of the patient.
Primary Purpose: Treatment
Official Title: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morphine
2mg preservative free morphine
Drug: 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
Drug: Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Other Name: Placebo




Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 24 hours ]
    Quantity of opioid used in 24 hours


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: up to 24 hours ]
    Pain Score: Likert full scale 1-10, with higher score indicating more pain

  2. Obstetric Quality of Recovery Score (OBSQ10) [ Time Frame: 24 hours ]
    OBSQ10 total score 0-100, with higher score indicating better health status

  3. 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.

  4. Number of participants with breast feeding success [ Time Frame: 1 week ]
    Participants will respond yes/no as to their breast feeding success and continuation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women in labor

Exclusion Criteria:

  • Not a candidate for neuraxial anesthesia
  • Patient refusal
  • Allergy to morphine
  • Patients with chronic pain syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017442


Contacts
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Contact: Daniel Katz, MD 212-241-0222 daniel.katz@mountsinai.org

Locations
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United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Daniel Katz, MD    212-241-0222    daniel.katz@mountsinai.org   
Contact: Eric Zhou, MD    212-241-7475    eric.zhou@mountsinai.org   
Principal Investigator: Daniel Katz, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Daniel Katz, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Daniel Katz, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04017442     History of Changes
Other Study ID Numbers: GCO 18-2789
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Katz, Icahn School of Medicine at Mount Sinai:
Postpartum depression
Postpartum anxiety
Postpartum opioids

Additional relevant MeSH terms:
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Depression
Depression, Postpartum
Behavioral Symptoms
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents