UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039351 |
|---|---|
| Receipt number | R000044869 |
| Scientific Title | A placebo-controlled, single-blind comparative study of postpartum analgesia result from epidural morphine administration in pregnant women undergoing epidural analgesia |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/09/24 16:53:54 |
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Basic information
Public title
Study of postpartum pain due to epidural morphine administration in pregnant women undergoing epidural analgesia
Acronym
Study of postpartum pain due to epidural morphine administration in pregnant women undergoing epidural analgesia
Scientific Title
A placebo-controlled, single-blind comparative study of postpartum analgesia result from epidural morphine administration in pregnant women undergoing epidural analgesia
Scientific Title:Acronym
A placebo-controlled, single-blind comparative study of postpartum analgesia result from epidural morphine administration in pregnant women undergoing epidural analgesia
Region
| Japan |
Condition
Condition
Pregnant woman receiving epidural analgesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effective dose of post-partum analgesia by administering morphine from epidural catheters to pregnant women who have delivered due to epidural analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative visual analogue scale (VAS) (return to the room,1, 2, 6, 12, 24,hours after delivery)for perineal pain and afterpains.
Key secondary outcomes
the time to the first request for additional analgesics.
the number of analgesic medications used for 24 h.
side effects (nausea, pruritus, urinary retention, and respiratory depression)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After delivery,0.75 mg of morphine is administered from the epidural catheter.
Interventions/Control_2
After delivery, saline is administered from the epidural catheter.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant woman undergoing epidural analgesia
Key exclusion criteria
Diabetes before pregnancy, substance abuse, chronic pain syndrome, antidepressant / antiepileptic medication
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | TOSHIYUKI |
| Middle name | |
| Last name | OKUTOMI |
Organization
School of medicine,Kitasato university
Division name
Division of obstetric anesthesiology,Kitasato university hospital
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
tokutomi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROAKI |
| Middle name | |
| Last name | KONDO |
Organization
School of medicine,Kitasato university
Division name
Division of obstetric anesthesiology,Kitasato university hospital
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
hkondo@kitasato-u.ac.jp
Sponsor or person
Institute
School of medicine,Kitasato university
Institute
Department
Personal name
Funding Source
Organization
School of medicine,Kitasato university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinri@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
80
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044869
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
