Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

NCT04017442 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 18-2789
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Pain; Postpartum Depression; Opioid Consumption

Keywords

Postpartum depression; Postpartum anxiety; Postpartum opioids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Score

  at 24 hours

• Obstetric Quality of Recovery Score (OBSQ10)

  24 hours

• Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10

  up to 6 weeks

• Number of Participants With Exclusive Breast Feeding

  1 week

Study Arms (2)

Morphine

EXPERIMENTAL

2mg preservative free morphine

Drug: Preservative Free Morphine

Saline

PLACEBO COMPARATOR

4 mL preservative free saline

Drug: Saline

Interventions

Preservative Free Morphine DRUG

After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Morphine

Saline DRUG

After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women in labor

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 33078388 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Daniel Katz
• Organization: Icahn School of Medicine at Mount Sinai

daniel.katz@mountsinai.org

212-241-7475

Study Officials

• Daniel Katz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind, prospective, randomized

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: October 19, 2019
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)