Phase 4
N=160
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
Postpartum Pain · Postpartum Depression · Opioid Consumption
Bottom Line
View on ClinicalTrials.gov: NCT04017442 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Opioid Consumption in MME — 0; 0 MME
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Preservative Free Morphine (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption in MME |
0; 0 | — |
| SECONDARY Pain Score |
2; 3 | — |
| SECONDARY Obstetric Quality of Recovery Score (OBSQ10) |
77; 85 | — |
| SECONDARY Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10 |
7; 5 | — |
| SECONDARY Number of Participants With Exclusive Breast Feeding |
22; 26; 26; 22 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pregnant women in labor
Exclusion Criteria
- Not a candidate for neuraxial anesthesia
- Patient refusal
- Allergy to morphine
- Patients with chronic pain syndromes
Data sourced from ClinicalTrials.gov (NCT04017442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.