UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021322 |
|---|---|
| Receipt number | R000024594 |
| Scientific Title | intravenous remifentanil analgesia during labor and decreasing maternal respiratory depression with mosaprid |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/03/25 09:31:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
intravenous remifentanil analgesia during labor and decreasing maternal respiratory depression with mosaprid
Acronym
remifentanil analgesia during labor and decreasing maternal respiratory depression with mosaprid
Scientific Title
intravenous remifentanil analgesia during labor and decreasing maternal respiratory depression with mosaprid
Scientific Title:Acronym
remifentanil analgesia during labor and decreasing maternal respiratory depression with mosaprid
Region
| Japan |
Condition
Condition
pain of labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study of decreasing opioid related maternal respiratory depression with mosaprid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain control, the presence or absence of maternal respiratory depression
Key secondary outcomes
Drug administration time, drug bolus administration number of times, the presence or absence of labor induction, patient satisfaction, final delivery mode, Apgar score, the presence or absence of umbilical cord arterial blood pH, birth weight, neonatal complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mosaprid administration
mosaprid 5mg per every 4 hours during first labor phase
Interventions/Control_2
no treatment
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
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant women who wish to relief labor pain patient obtained a consent with this study
Key exclusion criteria
Patients who can not consent.
Patient information can not be obtained necessary for analysis.
Patients of less than 22 weeks of pregnancy the fetus is alive.
Patients with a merger or a history of a high degree of hypersensitivity reactions to other drugs.
Patients with impaired consciousness.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kondoh |
Organization
Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3269
kondo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Io |
Organization
Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3269
Homepage URL
shinio@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Department of Gynecology and Obstetrics
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kurashiki Central Hospital Department of Obstetrics and Gynecology
Mitsubishi Kyoto Hospital Department of Obstetrics and Gynecology
Kosaka womens hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committe of Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院産科婦人科（京都府）, 倉敷中央病院産婦人科（岡山県）, 三菱京都病院産婦人科（京都府）, 小阪産病院産婦人科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
150
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
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 12 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024594
