Opioid Consumption, Postpartum Depression, Postpartum Pain
Conditions
Keywords
Postpartum depression, Postpartum anxiety, Postpartum opioids
Brief 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.
Detailed description
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.
Interventions
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
DRUGSaline
After delivery of the baby patients will receive via the epidural catheter prior to its removal.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Double blind, prospective, randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women in labor
Exclusion criteria
* Not a candidate for neuraxial anesthesia * Patient refusal * Allergy to morphine * Patients with chronic pain syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in MME | within 24 hours of delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | at 24 hours | Pain Score: Likert full scale 0-10, with higher score indicating more pain |
| Obstetric Quality of Recovery Score (OBSQ10) | 24 hours | OBSQ10 total score 0-100, with higher score indicating better health status |
| Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10 | up to 6 weeks | 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. |
| Number of Participants With Exclusive Breast Feeding | 1 week | Participants will respond yes/no as to their breast feeding success and continuation exclusively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morphine 2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery | 80 |
| Saline 4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery | 77 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 19 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Morphine | Saline |
|---|---|---|---|
| Age, Continuous | 33.0 years | 33.0 years | 33.0 years |
| BMI | 29.1 kg/m^2 | 29.3 kg/m^2 | 28.7 kg/m^2 |
| Gestational Age | 39.3 weeks | 39.4 weeks | 39.3 weeks |
| Gravidity 1 | 61 Participants | 33 Participants | 28 Participants |
| Gravidity 2 | 36 Participants | 18 Participants | 18 Participants |
| Gravidity 3 | 26 Participants | 16 Participants | 10 Participants |
| Gravidity >3 | 34 Participants | 13 Participants | 21 Participants |
| Height | 64.0 inches | 65.0 inches | 64.0 inches |
| Parity 0 | 81 Participants | 45 Participants | 36 Participants |
| Parity 1 | 43 Participants | 20 Participants | 23 Participants |
| Parity 2 | 15 Participants | 8 Participants | 7 Participants |
| Parity 3 | 8 Participants | 5 Participants | 3 Participants |
| Parity >3 | 10 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized African American | 15 Participants | 8 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 21 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Caucasian | 84 Participants | 44 Participants | 40 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 22 Participants | 12 Participants | 10 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 14 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 157 Participants | 80 Participants | 77 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| The Edinburgh Postnatal Depression Scale (EPDS) | 3 units on a scale | 4 units on a scale | 3 units on a scale |
| Weight | 170 lbs | 175 lbs | 165 lbs |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 77 |
| other Total, other adverse events | 0 / 80 | 0 / 77 |
| serious Total, serious adverse events | 0 / 80 | 0 / 77 |
Outcome results
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.
Time frame: within 24 hours of delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Morphine | Opioid Consumption in MME | 0 MME |
| Saline | Opioid Consumption in MME | 0 MME |
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.
Time frame: up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Morphine | Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10 | 7 Participants |
| Saline | Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10 | 5 Participants |
Secondary
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
Population: some participants lost to follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Morphine | Number of Participants With Exclusive Breast Feeding | 1 week | 22 Participants |
| Morphine | Number of Participants With Exclusive Breast Feeding | 6 weeks | 26 Participants |
| Saline | Number of Participants With Exclusive Breast Feeding | 1 week | 26 Participants |
| Saline | Number of Participants With Exclusive Breast Feeding | 6 weeks | 22 Participants |
Secondary
Obstetric Quality of Recovery Score (OBSQ10)
OBSQ10 total score 0-100, with higher score indicating better health status
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Morphine | Obstetric Quality of Recovery Score (OBSQ10) | 77 score on a scale |
| Saline | Obstetric Quality of Recovery Score (OBSQ10) | 85 score on a scale |
Secondary
Pain Score
Pain Score: Likert full scale 0-10, with higher score indicating more pain
Time frame: at 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Morphine | Pain Score | 2 score on a scale |
| Saline | Pain Score | 3 score on a scale |