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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032790
Receipt No. R000035682
Scientific Title Pregnancy outcomes in Japanese pregnant women with either chronic hypertension or white coat hypertension: a multicenter cohort study
Date of disclosure of the study information 2018/05/31
Last modified on 2021/06/01

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Basic information
Public title Pregnancy outcomes in Japanese pregnant women with either chronic hypertension or white coat hypertension: a multicenter cohort study
Acronym JP-WCH study
Scientific Title Pregnancy outcomes in Japanese pregnant women with either chronic hypertension or white coat hypertension: a multicenter cohort study
Scientific Title:Acronym JP-WCH study
Region
Japan

Condition
Condition hypertension, white coat hypertension, hypertensive disorders of pregnancy
Classification by specialty
Cardiology Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To distinguish white coat hypertension (WCH) and chronic hypertension (CH) by undergoing home blood pressure (HBP) measurement and/or ambulatory blood pressure measurement (ABPM) at <19 weeks of gestation during 2018/4/1 to 2020/3/31, in (A) pregnant women who are suspected with hypertension in a condition in which the blood pressure level measured in a clinical setting, and who have not been diagnosed as hypertension before the current pregnancy, and (B) pregnant women with previous diagnosis of hypertension, but who have not known their accurate diagnosis of whether CH or WCH. Finally, to compare the incidences of preeclampsia (PE), gestational hypertension (GH), and related diseases of hypertensive disorders of pregnancy (HDP) in women with WCH or CH, after detecting all women with CH and/or WCH at <20 weeks of gestation during 2018/4/1 to 2020/3/31.
Basic objectives2 Others
Basic objectives -Others adverse events by measuring home blood pressure
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes preeclampsia (PE) + superimposed preeclampsia (sPE)
Key secondary outcomes GH
PE
sPE
gestational proteinuria
eclampsia
HELLP syndrome
acute fatty liver of pregnancy (AFLP)
posterior reversible encephalopathy syndrome (PRES)
aggravation of hypertension
pulmonary edema
placental abruption
disseminated intravascular coagulation syndrome (DIC)
intracranial hemorrohage
labor onset hypertension
puerperal period onset hypertension
intrauterine fetal death at 12 to 21 weeks of gestation
abortion at 12 to 21 weeks of gestation (not included stillbirth)
stillbirth at 22 and/or later than 22 weeks of gestation
extremely low birth weight infant
very low birth weight infant
low birth weight infant
non-reassurring fetal status (NRFS)
fetal growth restriction (FGR)
small-for-gestational-age (SGA) infant
light-for-gestational-age (LGA) infant
early neonatal death (END)
perinatal death (PD)
neonatal death (ND)
discharge with infant death
extremely preterm birth
very preterm birth
preterm birth at <35 weeks of gestation
preterm birth
cesarean delivery
emergent cesarean delivery
maternal death

Base
Study type Observational

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
16 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria At <19 weeks of gestation during 2018/4/1 to 2020/3/31, in (A) pregnant women who are suspected with hypertension in a condition in which the blood pressure level measured in a clinical setting, and who have not been diagnosed as hypertension before the current pregnancy, and (B) pregnant women with previous diagnosis of hypertension, but who have not known their accurate diagnosis of whether CH or WCH.
Key exclusion criteria Pregnant women for whom research investigators judge them to be very difficult to include this research, or those going to elementary school or junior high school.
Target sample size 630

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihide Ohkuchi
Organization Jichi Medical University Hosptal
Division name Maternal Fetal Intensive Care Unit
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0498 Japan
TEL 0285-58-7376
Email okuchi@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Hirashima
Organization Jichi Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, 329-0498 Japan
TEL 0285-58-7376
Homepage URL
Email chikako@jichi.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Jichi Medical University
Institute
Department

Funding Source
Organization Japan Society for the Study of Hypertension in Pregnancy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 RinDai17-173
Org. issuing International ID_1 Jichi Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 自治医科大学
富山大学 医学部
埼玉医大総合医療センター 
愛知医科大学
聖バルナバ病院
愛媛大学大学院医学系研究科
昭和大学
東京医科大学
順天堂大学医学部
大阪大学大学院医学系研究科
東北医科薬科大学医学部
福岡市立こども病院
東京都立墨東病院
東京女子医科大学 
藤田保健衛生大学
熊本大学大学院生命科研究部
浜の町病院
独立行政法人 国立病院機構 相模原病院
亀田総合病院
獨協医大埼玉医療センター
順天堂大学医学部附属浦安病院
北見赤十字病院
広島大学病院
独立行政法人 国立病院機構 岩国医療センター
市立東大阪医療センター 
島根大学
富山県立中央病院
群馬県立小児医療センター
長崎みなとメディカルセンター
北海道大学病院
大阪急性期総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 31 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 02 Day
Date of IRB
2017 Year 12 Month 07 Day
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [study 1] a multicenter prospective observational study.
[study 2] a multicenter retrospective cohort study, which will start at 2020/4/1.

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035682

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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