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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

Primary Purpose

Postpartum Pain, Postpartum Depression, Opioid Consumption

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Preservative Free Morphine
Saline
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Pain focused on measuring Postpartum depression, Postpartum anxiety, Postpartum opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women in labor

Exclusion Criteria:

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Morphine

Saline

Arm Description

2mg preservative free morphine

4 mL preservative free saline

Outcomes

Primary Outcome Measures

Opioid Consumption
Quantity of opioid used in 24 hours

Secondary Outcome Measures

Pain Score
Pain Score: Likert full scale 1-10, with higher score indicating more pain
Obstetric Quality of Recovery Score (OBSQ10)
OBSQ10 total score 0-100, with higher score indicating better health status
Edinburgh Postnatal Depression Scale (EPDS)
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
Participants will respond yes/no as to their breast feeding success and continuation

Full Information

First Posted
July 10, 2019
Last Updated
September 20, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04017442
Brief Title
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
Official Title
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Pain, Postpartum Depression, Opioid Consumption
Keywords
Postpartum depression, Postpartum anxiety, Postpartum opioids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind, prospective, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Experimental
Arm Description
2mg preservative free morphine
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
4 mL preservative free saline
Intervention Type
Drug
Intervention Name(s)
Preservative Free Morphine
Intervention Description
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo
Intervention Description
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Quantity of opioid used in 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain Score: Likert full scale 1-10, with higher score indicating more pain
Time Frame
up to 24 hours
Title
Obstetric Quality of Recovery Score (OBSQ10)
Description
OBSQ10 total score 0-100, with higher score indicating better health status
Time Frame
24 hours
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
up to 6 weeks
Title
Number of participants with breast feeding success
Description
Participants will respond yes/no as to their breast feeding success and continuation
Time Frame
1 week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Katz, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33078388
Citation
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.
Results Reference
derived

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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

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