Trial Outcomes & Findings for Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery (NCT NCT04017442)
NCT ID: NCT04017442
Last Updated: 2024-08-14
Results Overview
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.
COMPLETED
PHASE4
160 participants
within 24 hours of delivery
2024-08-14
Participant Flow
Participant milestones
| Measure |
Morphine
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
| Measure |
Morphine
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
21
|
19
|
Baseline Characteristics
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery
Baseline characteristics by cohort
| Measure |
Morphine
n=80 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=77 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
n=39 Participants
|
33.0 years
n=41 Participants
|
33.0 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
157 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
BMI
|
29.3 kg/m^2
n=39 Participants
|
28.7 kg/m^2
n=41 Participants
|
29.1 kg/m^2
n=35 Participants
|
|
Weight
|
175 lbs
n=39 Participants
|
165 lbs
n=41 Participants
|
170 lbs
n=35 Participants
|
|
Height
|
65.0 inches
n=39 Participants
|
64.0 inches
n=41 Participants
|
64.0 inches
n=35 Participants
|
|
Gestational Age
|
39.4 weeks
n=39 Participants
|
39.3 weeks
n=41 Participants
|
39.3 weeks
n=35 Participants
|
|
Gravidity
1
|
33 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
61 Participants
n=35 Participants
|
|
Gravidity
2
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Gravidity
3
|
16 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Gravidity
>3
|
13 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Parity
0
|
45 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Parity
1
|
20 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Parity
2
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Parity
3
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Parity
>3
|
2 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
The Edinburgh Postnatal Depression Scale (EPDS)
|
4 units on a scale
n=39 Participants
|
3 units on a scale
n=41 Participants
|
3 units on a scale
n=35 Participants
|
PRIMARY outcome
Timeframe: within 24 hours of deliveryQuantity 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.
Outcome measures
| Measure |
Morphine
n=80 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=77 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Opioid Consumption in MME
|
0 MME
Interval 0.0 to 47.5
|
0 MME
Interval 0.0 to 72.0
|
SECONDARY outcome
Timeframe: at 24 hoursPain Score: Likert full scale 0-10, with higher score indicating more pain
Outcome measures
| Measure |
Morphine
n=75 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=70 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Pain Score
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.5 to 5.0
|
SECONDARY outcome
Timeframe: 24 hoursOBSQ10 total score 0-100, with higher score indicating better health status
Outcome measures
| Measure |
Morphine
n=80 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=77 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Obstetric Quality of Recovery Score (OBSQ10)
|
77 score on a scale
Interval 60.0 to 90.0
|
85 score on a scale
Interval 71.0 to 92.0
|
SECONDARY outcome
Timeframe: up to 6 weeksNumber 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.
Outcome measures
| Measure |
Morphine
n=80 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=77 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Number of Participants With Edinburgh Postnatal Depression Scale (EPDS) >10
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: some participants lost to follow up
Participants will respond yes/no as to their breast feeding success and continuation exclusively.
Outcome measures
| Measure |
Morphine
n=80 Participants
2mg preservative free morphine (4mL) via the epidural catheter within 1 hour of vaginal delivery
|
Saline
n=77 Participants
4 mL preservative free saline via the epidural catheter within 1 hour of vaginal delivery
|
|---|---|---|
|
Number of Participants With Exclusive Breast Feeding
1 week
|
22 Participants
|
26 Participants
|
|
Number of Participants With Exclusive Breast Feeding
6 weeks
|
26 Participants
|
22 Participants
|
Adverse Events
Morphine
Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel Katz
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place