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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04017442
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
40.4
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blind, prospective, randomizedDouble 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
Actual Study Start Date :
Oct 19, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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 Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opioid Consumption [24 hours]

      Quantity of opioid used in 24 hours

    Secondary Outcome Measures

    1. Pain Score [up to 24 hours]

      Pain Score: Likert full scale 1-10, with higher score indicating more pain

    2. Obstetric Quality of Recovery Score (OBSQ10) [24 hours]

      OBSQ10 total score 0-100, with higher score indicating better health status

    3. Edinburgh Postnatal Depression Scale (EPDS) [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 [1 week]

      Participants will respond yes/no as to their breast feeding success and continuation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pregnant women in labor
    Exclusion Criteria:

    • Not a candidate for neuraxial anesthesia

    • Patient refusal

    • Allergy to morphine

    • Patients with chronic pain syndromes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Katz, Associate Professor, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT04017442
    Other Study ID Numbers:
    • GCO 18-2789
    First Posted:
    Jul 12, 2019
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Daniel Katz, Associate Professor, Icahn School of Medicine at Mount Sinai
    Postpartum depression
    Postpartum anxiety
    Postpartum opioids
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression
    Morphine

    Study Results

    No Results Posted as of Dec 17, 2021