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NCT04017442 · ClinicalTrials.gov registry record · Phase 4

Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery

A Phase 4 study of Postpartum Depression and Postpartum Pain, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
160
Enrollment target
1
Study location

NCT04017442 is a Phase 4 study of Postpartum Depression and Postpartum Pain that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 160 participants, below the 530-participant average among 38 other Postpartum Depression trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04017442, a Phase 4 study of Postpartum Depression and Postpartum Pain, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
160 participants
Enrollment target
1
Study location

Study 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 Studied

Postpartum Depression Postpartum Pain Opioid Consumption

Interventions

  • DRUG Saline
  • DRUG Preservative Free Morphine

Study Locations (1)

New York

  • Mount Sinai Hospital - New York

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2019-10-19
Est. Completion 2023-08-31
Phase Phase 4

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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What the Registry Record Tells You About NCT04017442

The ClinicalTrials.gov registry entry for NCT04017442 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 530-participant average among 38 other Postpartum Depression trials with a reported enrollment target (70% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT04017442 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04017442 about?

NCT04017442 is a clinical study titled "Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery". 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.

What is the current status of trial NCT04017442?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2019-10-19. Estimated completion is 2023-08-31.

What conditions does trial NCT04017442 study?

This clinical trial studies the following conditions: Postpartum Depression, Postpartum Pain, Opioid Consumption.

What interventions are being tested in trial NCT04017442?

The interventions under investigation include: Saline (DRUG), Preservative Free Morphine (DRUG).

Who is sponsoring clinical trial NCT04017442?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04017442 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.