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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: Completed Phase 4 study of Postpartum Depression and Postpartum Pain, sponsored by Icahn School of Medicine at Mount Sinai.
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 472-participant average among 47 other Postpartum Depression trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Saline
- DRUG Preservative Free Morphine
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2019-10-19 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 4 |
What the finished NCT04017442 record still lists
NCT04017442 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 472-participant average among 47 other Postpartum Depression trials with a reported enrollment target (66% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Postpartum Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04017442's enrollment target sits among peer trials
160 21st of 47 higher than 27 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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