UMIN-CTR Clinical Trial

Basic information
Public title	Low-dose aspirin for reduction in preeclampsia risk in high-risk women in Japan.
Acronym	Low-dose aspirin for reduction in preeclampsia risk
Scientific Title	Low-dose aspirin for reduction in preeclampsia risk in high-risk women in Japan.
Scientific Title:Acronym	Low-dose aspirin for reduction in preeclampsia risk
Region	Japan

Condition
Condition	preeclampsia
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the effect of low-dose aspirin on the incidence of preeclampsia in high-risk women
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence of preeclampsia in high-risk women(previous preeclampsia,chronic hypertension,diabetes,autoimmune disease,blood pressure>130/80 at the first visit and BMI greater than 35)
Key secondary outcomes	the incidence of severe preeclampsia,preterm labor and fetal growth restriction in high-risk women

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver
Interventions/Control_1	initiation of low-dose aspirin started from 12 to 16 weeks gestation and terminated below 28 weeks gestation
Interventions/Control_2	no initiation of low-dose aspirin to control
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	12 weeks-old <=
Age-upper limit	28 weeks-old >
Gender	Female
Key inclusion criteria	women who first visit before 16weeks gestation at our center and meet a criterion for the following lists 1 previous preeclampsia 2 chronich hypertension 3 diabetes 4 autoimmune disease 5 blood pressure>130/80 at the first visit 6 BMI greater than 35
Key exclusion criteria	1 multiple pregnancy 2 non-Japanease 3 low-dose aspirin initiated under 12 weeks'gestation for other reason 4 women who are out of sympathy with a plan
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruna Kawaguchi
Organization	Osaka Medical Center and Research Institute for Maternal and Child Health
Division name	the Department of Maternal Fetal Medicine
Zip code
Address	840 Murodocho Izumi city,Osaka
TEL	0725-56-1220
Email	haruna@mch.pref.osaka.jp

Public contact
Name of contact person	1st name Middle name Last name Haruna Kawaguchi
Organization	Osaka Medical Center and Research Institute for Maternal and Child Health
Division name	the Department of Maternal Fetal Medicine
Zip code
Address	840 Murodocho Izumi city,Osaka
TEL	0725-56-1220
Homepage URL
Email	haruna@mch.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center and Research Institute for Maternal and Child Health
Institute
Department

Funding Source
Organization	self
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 12 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
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	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 12 Month 01 Day
Last modified on	2022 Year 12 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023103