UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032706 |
|---|---|
| Receipt number | 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 18:16:32 |
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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
| Obstetrics 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
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
michihata-tky@umin.org
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037298
| 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 |
