A Phase 4 interventional study of Preservative Free Morphine and Saline in Postpartum Pain, Postpartum Depression and Opioid Consumption, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Treatment
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.
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 160 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
2mg preservative free morphine
Drug: Preservative Free Morphine
4 mL preservative free saline
Drug: Saline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Also known as: Placebo
Opioid Consumption in MME
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.
Time frame: within 24 hours of delivery
Pain Score
Pain Score: Likert full scale 0-10, with higher score indicating more pain
Time frame: at 24 hours
Obstetric Quality of Recovery Score (OBSQ10)
OBSQ10 total score 0-100, with higher score indicating better health status
Time frame: 24 hours
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10
Number of Participants with positive EPDS screen in the 6-week post-delivery EPDS defined as a score higher than 10. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms.
Time frame: up to 6 weeks
Number of Participants With Exclusive Breast Feeding
Participants will respond yes/no as to their breast feeding success and continuation exclusively.
Time frame: 1 week
| Milestone | Morphine | Saline |
|---|---|---|
| Started | 80 | 80 |
| Completed | 59 | 58 |
| Not completed | 21 | 22 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Lost to follow-up | 21 | 19 |
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.
| MME | Morphine | Saline |
|---|---|---|
| Opioid Consumption in MME | 0 (0 to 47.5) | 0 (0 to 72) |
Pain Score: Likert full scale 0-10, with higher score indicating more pain
| score on a scale | Morphine | Saline |
|---|---|---|
| Pain Score | 2 (1 to 4) | 3 (1.5 to 5) |
OBSQ10 total score 0-100, with higher score indicating better health status
| score on a scale | Morphine | Saline |
|---|---|---|
| Obstetric Quality of Recovery Score (OBSQ10) | 77 (60 to 90) | 85 (71 to 92) |
Number of Participants with positive EPDS screen in the 6-week post-delivery EPDS defined as a score higher than 10. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms.
| Participants | Morphine | Saline |
|---|---|---|
| Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10 | 7 | 5 |
Participants will respond yes/no as to their breast feeding success and continuation exclusively.
| Participants | Morphine | Saline |
|---|---|---|
| 1 week | 22 | 26 |
| 6 weeks | 26 | 22 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Morphine | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Saline | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Age, Continuous(years) | Morphine | Saline | Total |
|---|---|---|---|
| Median | 33.0 (18.0 to 47.0) | 33.0 (21.0 to 51.0) | 33.0 (18.0 to 51.0) |
| Sex: Female, Male(Participants) | Morphine | Saline | Total |
|---|---|---|---|
| Female | 80 | 77 | 157 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Morphine | Saline | Total |
|---|---|---|---|
| Caucasian | 44 | 40 | 84 |
| African American | 8 | 7 | 15 |
| Asian | 9 | 12 | 21 |
| Hispanic/Latino | 12 | 10 | 22 |
| Other | 7 | 7 | 14 |
| Missing | 0 | 1 | 1 |
| BMI(kg/m^2) | Morphine | Saline | Total |
|---|---|---|---|
| Median | 29.3 (19.5 to 54.9) | 28.7 (20.5 to 63.6) | 29.1 (19.5 to 63.6) |
| Weight(lbs) | Morphine | Saline | Total |
|---|---|---|---|
| Median | 175 (117 to 300) | 165 (105 to 394) | 170 (105 to 394) |
| Height(inches) | Morphine | Saline | Total |
|---|---|---|---|
| Median | 65.0 (60.0 to 71.0) | 64.0 (59.0 to 71.0) | 64.0 (59.0 to 71.0) |
| Gestational Age(weeks) | Morphine | Saline | Total |
|---|---|---|---|
| Median | 39.4 (35.6 to 41.6) | 39.3 (34.4 to 41.4) | 39.3 (34.4 to 41.6) |
| Gravidity(Participants) | Morphine | Saline | Total |
|---|---|---|---|
| 1 | 33 | 28 | 61 |
| 2 | 18 | 18 | 36 |
| 3 | 16 | 10 | 26 |
| >3 | 13 | 21 | 34 |
2 further baseline measures are reported on the registry.
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Icahn School of Medicine at Mount Sinai