Trial Outcomes & Findings for Epidural Morphine Following Vaginal Delivery (NCT NCT00803114)
NCT ID: NCT00803114
Last Updated: 2009-01-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
228 participants
Primary outcome timeframe
24 hours postpartum
Results posted on
2009-01-14
Participant Flow
Parturients were recruited at Mount Sinai Hospital labor and delivery unit. Recruitment took place between March 2002 and November 2004.
Parturients were approached prior to delivery if they had received epidural analgesia for labor. Following a vaginal delivery, the subject was randomized to one of the two arms.
Participant milestones
| Measure |
Epidural Morphine
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
115
|
|
Overall Study
COMPLETED
|
113
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidural Morphine Following Vaginal Delivery
Baseline characteristics by cohort
| Measure |
Epidural Morphine
n=113 Participants
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
n=115 Participants
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
32.1 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
31.8 years
STANDARD_DEVIATION 4.9 • n=107 Participants
|
32.0 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
87 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-caucasian
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing information
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Operative vaginal delivery
Operative vaginal delivery
|
38 participants
n=99 Participants
|
34 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Operative vaginal delivery
Spontaneous vaginal delivery
|
75 participants
n=99 Participants
|
81 participants
n=107 Participants
|
156 participants
n=206 Participants
|
|
Parity
Primiparous
|
76 participants
n=99 Participants
|
79 participants
n=107 Participants
|
155 participants
n=206 Participants
|
|
Parity
Multiparous
|
37 participants
n=99 Participants
|
36 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Perineal Trauma
Second degree tear or greater
|
82 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Perineal Trauma
First degree tear or less
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Maternal Body Mass Index (BMI)
|
29.0 kg/m2
STANDARD_DEVIATION 5.9 • n=99 Participants
|
29.0 kg/m2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
29.0 kg/m2
STANDARD_DEVIATION 6.2 • n=206 Participants
|
|
Neonatal Birth Weight
|
3.4 kilograms
STANDARD_DEVIATION 0.51 • n=99 Participants
|
3.4 kilograms
STANDARD_DEVIATION 0.46 • n=107 Participants
|
3.4 kilograms
STANDARD_DEVIATION 0.48 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours postpartumPopulation: Analysis by intention to treat.
Outcome measures
| Measure |
Epidural Morphine
n=113 Participants
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
n=115 Participants
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
|---|---|---|
|
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
|
8 participants
|
37 participants
|
SECONDARY outcome
Timeframe: HoursAll participants requested analgesia at least once during their hospitalization
Outcome measures
| Measure |
Epidural Morphine
n=113 Participants
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
n=115 Participants
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
|---|---|---|
|
Time to First Request for Analgesia
|
22.9 hours
Standard Deviation 4.0
|
18.9 hours
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: by 24 hours postpartumParticipants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with "no pain in my bottom" to the other end anchored with "the worst pain in my bottom that I can imagine"
Outcome measures
| Measure |
Epidural Morphine
n=113 Participants
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
n=115 Participants
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
|---|---|---|
|
Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic
|
0.3 scores on a scale
Standard Deviation 1.4
|
1.6 scores on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: at 24 hours postpartum5 point Likert scale asking for agreement with the statement "I was satisfied with my pain relief for the pain in my bottom during the first day after delivery". Scale ranged from strongly disagree to strongly agree.
Outcome measures
| Measure |
Epidural Morphine
n=113 Participants
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
|
Placebo
n=115 Participants
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
|
|---|---|---|
|
Maternal Satisfaction With Perineal Pain Management
Strongly Disagree
|
1 participants
|
3 participants
|
|
Maternal Satisfaction With Perineal Pain Management
Disagree
|
9 participants
|
11 participants
|
|
Maternal Satisfaction With Perineal Pain Management
Not sure
|
6 participants
|
8 participants
|
|
Maternal Satisfaction With Perineal Pain Management
Agree
|
43 participants
|
38 participants
|
|
Maternal Satisfaction With Perineal Pain Management
Strongly Agree
|
45 participants
|
45 participants
|
|
Maternal Satisfaction With Perineal Pain Management
Missing information
|
9 participants
|
10 participants
|
SECONDARY outcome
Timeframe: at 24 hours postpartumNumber of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum
Outcome measures
Outcome data not reported
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place