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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Experimental | 2mg preservative free morphine |
|
| Saline | Placebo Comparator | 4 mL preservative free saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative Free Morphine | Drug | After delivery of the baby patients will receive via the epidural catheter prior to its removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 24 hours of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain Score: Likert full scale 0-10, with higher score indicating more pain | at 24 hours |
| Obstetric Quality of Recovery Score (OBSQ10) | OBSQ10 total score 0-100, with higher score indicating better health status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33078388 | Derived | Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Morphine | 2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery |
| FG001 | Saline | 4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morphine | 2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery |
| BG001 | Saline | 4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | MME | within 24 hours of delivery |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Morphine | 2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Katz | Icahn School of Medicine at Mount Sinai | 212-241-7475 | daniel.katz@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Jul 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2019 | Jul 23, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Double blind, prospective, randomized
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The only individual that will know to which group the patient was assigned is the individual on the study team who is drawing up the medication. This individual will have no other role in the assessment or evaluation of the patient.
| Saline | Drug | After delivery of the baby patients will receive via the epidural catheter prior to its removal. |
|
|
| 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. | 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. | 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
| Weight | Median | Full Range | lbs |
|
| Height | Median | Full Range | inches |
|
| Gestational Age | Median | Full Range | weeks |
|
| Gravidity | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| The Edinburgh Postnatal Depression Scale (EPDS) | A 10-item instrument to assess postpartum depression, with total score from 0-30. Higher score indicates more depressed symptoms. | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Secondary | Pain Score | Pain Score: Likert full scale 0-10, with higher score indicating more pain | Posted | Median | Inter-Quartile Range | score on a scale | at 24 hours |
|
|
|
| Secondary | Obstetric Quality of Recovery Score (OBSQ10) | OBSQ10 total score 0-100, with higher score indicating better health status | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| Secondary | Number of Participants With Exclusive Breast Feeding | Participants will respond yes/no as to their breast feeding success and continuation exclusively. | some participants lost to follow up | Posted | Count of Participants | Participants | 1 week |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Saline | 4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery | 0 | 77 | 0 | 77 | 0 | 77 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D017670 |
| Sodium Compounds |
| 6 weeks |
|
|