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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032706
Receipt No. R000037298
Scientific Title Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Date of disclosure of the study information 2018/05/24
Last modified on 2018/05/24

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Basic information
Public title Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Acronym Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Scientific Title Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Scientific Title:Acronym Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Region
Japan

Condition
Condition Hyperemesis gravidarum
Classification by specialty
Obsterics and gynecology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hyperemesis gravidarum (HG) is treated with several Kampo medicines, including Sho-hange-kabukuryou-to, Touki-syakuyakusan, and Hange-kouboku-to. Using a large health care administrative database, we aimed to clarify whether these medicines are safe for fetuses and whether they reduce hospitalizations and medical costs among pregnant women with HG.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Safety outcomes included newborns' congenital anomalies, low birthweight (ICD-10, P070 or P071), and preterm birth (P072 or P073). Congenital anomalies were defined according to the criteria of the Congenital Anomaly Register for Oxfordshire, Berkshire and Buckinghamshire.
Key secondary outcomes For mothers with hyperemesis gravidarum, we defined effectiveness outcomes as unplanned hospital admission for treating hyperemesis gravidarum and total medical costs during pregnancy within 20 weeks of gestation.

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
19 years-old <=
Age-upper limit
99 years-old >=
Gender Female
Key inclusion criteria All mothers who were admitted to obstetric clinics or hospitals for delivery from January 2005 to December 2016 and on their newborns.
Key exclusion criteria We excluded mothers aged under 19 years.
Target sample size 100000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taisuke Jo
Organization The University of Tokyo
Division name Department of Health Services Research, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL +81-3-5841-1887
Email jo-taisuke@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Michihata
Organization The University of Tokyo
Division name Department of Health Services Research, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL +81-3-5841-1887
Homepage URL
Email michihata-tky@umin.org

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Tsumura & Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 05 Month 24 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 Completed
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information From the Japan Medical Data Center database (JMDC Co., Ltd., Tokyo, Japan), we extracted data on pregnant women aged older than 18 years admitted to obstetric clinics or hospitals for delivery from 2005 to 2016. Eligible patients were classified into three groups: Kampo medicines for HG, other medicines for HG, and without HG. The safety outcome measures were neonatal outcomes (congenital anomalies, low birthweight, and preterm birth), and the effectiveness measures were mother's unplanned hospitalization for HG and total medical costs within 20 weeks of gestation.

Management information
Registered date
2018 Year 05 Month 24 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037298

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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