Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

NCT ID: NCT04017442

Last Updated: 2024-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-19

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Postpartum Pain Postpartum Depression Opioid Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, prospective, randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Morphine

2mg preservative free morphine

Group Type EXPERIMENTAL

Preservative Free Morphine

Intervention Type DRUG

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

Saline

4 mL preservative free saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Preservative Free Morphine

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Pregnant women in labor

Exclusion Criteria

* Not a candidate for neuraxial anesthesia
* Patient refusal
* Allergy to morphine
* Patients with chronic pain syndromes
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Daniel Katz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33078388 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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GCO 18-2789

Identifier Type: -

Identifier Source: org_study_id

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