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Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

NCT04017442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-08-14

Study results available
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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

Interventions

DRUG

Preservative Free Morphine

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

DRUG

Saline

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

Sponsors & Collaborators

Principal Investigators

  • Daniel Katz, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-19
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017442 on ClinicalTrials.gov