UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032790 |
|---|---|
| Receipt number | 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 | 2021/12/08 12:14:17 |
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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 | Obstetrics 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
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
chikako@jichi.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Jichi Medical University
Institute
Department
Personal name
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
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
No longer recruiting
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 | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035682
| 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 |
