UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Effectiveness of Japanese Herbal Kampo Medicines for Treating Hyperemesis Gravidarum
Title of the study (Brief title)	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	Taisuke Jo
Organization	The University of Tokyo
Division name	Department of Health Services Research, Graduate School of Medicine
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	Nobuaki Michihata
Organization	The University of Tokyo
Division name	Department of Health Services Research, Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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