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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

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ClinicalTrials.gov Identifier: NCT04017442
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Katz, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE October 19, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
Opioid Consumption [ Time Frame: 24 hours ]
Quantity of opioid used in 24 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Pain Score [ Time Frame: up to 24 hours ]
    Pain Score: Likert full scale 1-10, with higher score indicating more pain
  • Obstetric Quality of Recovery Score (OBSQ10) [ Time Frame: 24 hours ]
    OBSQ10 total score 0-100, with higher score indicating better health status
  • 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.
  • Number of participants with breast feeding success [ Time Frame: 1 week ]
    Participants will respond yes/no as to their breast feeding success and continuation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
Official Title  ICMJE Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Postpartum Pain
  • Postpartum Depression
  • Opioid Consumption
Intervention  ICMJE
  • Drug: Preservative Free Morphine
    After delivery of the baby patients will receive via the epidural catheter prior to its removal.
  • Drug: Saline
    After delivery of the baby patients will receive via the epidural catheter prior to its removal.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Morphine
    2mg preservative free morphine
    Intervention: Drug: Preservative Free Morphine
  • Placebo Comparator: Saline
    4 mL preservative free saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women in labor

Exclusion Criteria:

  • Not a candidate for neuraxial anesthesia
  • Patient refusal
  • Allergy to morphine
  • Patients with chronic pain syndromes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Katz, MD 212-241-0222 daniel.katz@mountsinai.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017442
Other Study ID Numbers  ICMJE GCO 18-2789
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Katz, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Katz, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP