UMIN-CTR Clinical Trial

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	Obsterics 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
Last 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
Email	kondo@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email	shinio@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Department of Gynecology and Obstetrics
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024594