臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 08, 2018
Last modified on	Mar. 18, 2019
Trial ID	jRCT1090220328

Scientific Title	An effectiveness study of a continuous approach from routine intrapartum care to emergency obstetric care on reducing severe maternal outcomes: A stepped-wedge cluster randomized control trial in Lao P.D.R (CARE Trial: Continuous Approach on improving Routine care in childbirth and Emergency obstetric care)
Public Title	An effectiveness study of a continuous approach from routine intrapartum care to emergency obstetric care on reducing severe maternal outcomes through nation-wide rollout in Lao PDR

Contact for Scientific Queries	Investigator Name	Shogo Kubota
	Investigator Organization	World Health Orgnization
	Address	Ban Phonxay, That Luang Road, Vientiane, Lao P.D.R.
	TEL	856-214-413431
	E-mail	kubotas@who.int
Contact for Public Queries	Contact Name	Shogo Kubota
	Contact Organization	World Health Orgnization
	Address	Ban Phonxay, That Luang Road, Vientiane, Lao P.D.R.
	TEL	856-21-413431
	E-mail	kubotas@who.int

Recruitment Status	PENDING

Date of First Enrollment		May. 01, 2018
Planned Number of Subjects		576
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Stepped-wedge cluster randomized control trial
	Type of Control
	Trial Blinding Schema	single blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Women who was diagnosed as pre-eclampsia, eclampsia, postpartum hemorrhage, perinatal infection or other maternal complication in the target hospitals within the study period
	Exclusion Criteria	None
	Minimum Age	No limit
	Maximum Age	No limit
	Sex of Participants	Female
Trial Indication(s)		Severe pre-eclampsia, eclampsia, postpartum hemorrhage, perinatal maternal infection, and other maternal severe outcome cases
Intervention(s)		Intervention type: Name of intervention:Package on improving continuous care in childbirth and emergency obstetric care Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application: Dose per administration:5 days N/A day Dosing frequency / Frequency of use:ONCE N/A Planned duration of intervention:4 months Intended dose regimen:N/A detailes of teratment arms:Training on continuous care in childbirth and emergency obstetric care ? 3 days, and audit and feedback after 3 months ? 2 days Comparative intervention name:No intervention Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application: Dose per administration:N/A N/A N/A Dosing frequency / Frequency of use: N/A Planned duration of intervention:N/A Intended dose regimen:N/A
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Risk of severe maternal outcomes among those with complications
Secondary Outcome(s)		Quality of care for severe pre-eclampsia, eclampsia, postpartum hemorrhage

Primary Sponsor	University of Tokyo
Secondary Sponsor	Ministry of Health, University of Health Science in Laos, WHO

Sources of funding	none

Name of Ethics Committee	Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
TEL	+81-3-5841-0818
FAX
E-Mail
Ethics Committee Website	http://u-tokyo-ohrs.jp/
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval	applying

Date of approved

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Secondary Study ID	N/A
Issuer Name	N/A

Secondary Study ID	JMA-IIA00328
Issuer Name

Countrie(s) of Recruitment

History of Changes

No	Publication date
2	Mar. 18, 2019	(this page)	Changes
1	Feb. 08, 2018	Detail

List of change history