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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039351
Receipt No. 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 2020/08/14

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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

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
Email 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
Email hkondo@kitasato-u.ac.jp

Sponsor
Institute School of medicine,Kitasato university
Institute
Department

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
Email 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
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 Open public recruiting
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
2020 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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