Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

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
• Conditions: Postpartum Depression; Opioid Consumption; Postpartum Pain
• Intervention / Treatment: Drug: Preservative Free Morphine; Drug: Saline

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): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption in MME	Quantity of opioid in morphine milligram equivalents (MME) used within 24 hours of delivery. The conversions from opioids to MME were as follows: 2 mg oral hydromorphone as 8 MME, 5 mg oxycodone 7.5 MME. To convert the PO hydromorphone to MME, IV hydromorphone was converted to morphine with a 4:1 ratio to convert to morphine followed by a 1:3 ratio to convert IV to PO.	within 24 hours of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric Quality of Recovery Score (OBSQ10)	OBSQ10 total score 0-100, with higher score indicating better health status	24 hours
Pain Score	Pain Score: Likert full scale 0-10, with higher score indicating more pain	at 24 hours
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10	Number of Participants with positive EPDS screen in the 6-week post-delivery EPDS defined as a score higher than 10. 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 Exclusive Breast Feeding	Participants will respond yes/no as to their breast feeding success and continuation exclusively.	1 week

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Daniel Katz, MD, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

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): August 14, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Postpartum depression; Postpartum anxiety; Postpartum opioids
• 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