UMIN-CTR Clinical Trial

Basic information
Public title	Examination of relationship between scavenging effect of serum albumin in maternal blood and oxygen species in pregnant women with hypertensive disorders of pregnancy
Acronym	Examination of relationship between scavenging effect of serum albumin in maternal blood and oxygen species in pregnant women with hypertensive disorders of pregnancy
Scientific Title	Examination of relationship between scavenging effect of serum albumin in maternal blood and oxygen species in pregnant women with hypertensive disorders of pregnancy
Scientific Title:Acronym	Examination of relationship between scavenging effect of serum albumin in maternal blood and oxygen species in pregnant women with hypertensive disorders of pregnancy
Region	Japan

Condition
Condition	pregnant women with hypetensive disorders ofpregnancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In pregnant women with uncomplicated pregnancies and hypetensive disorders ofpregnancy,we examinate the direct scavenging effect of serum albumin for production of oxygen speciesby by clarifying relation between blood or urinary human mercaptalbumin and human non mercaptalbumin .
Basic objectives2	Others
Basic objectives -Others	To find the proportion of human non mercaptalbumin reveals the effect of albumin for oxygen species in pregnant women with hypetensive disorders ofpregnancy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Value of blood or urinary human mercaptalbumin and human non mercaptalbumin in pregnant women with uncomplicated pregnancies and hypetensive disorders of pregnancy
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Collecting blood sampling and urinalysis around 34 weeks gestation and one month after delivery in women with no complecated pregnancy
Interventions/Control_2	Collecting blood sampling and urinalysis around 34 weeks gestation and one month after delivery in women with hypertensive disorders of pregnancy
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	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	Women with no complecated pregnancy and hypertensive disorders of pregnancy
Key exclusion criteria	Pregnant women who have difficulty in cooperating with this study or who have determined that participation in this study is not appropriate
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Saitou
Organization	Aichi Medical University Hospital
Division name	obstetoric and gynecology
Zip code	480-1195
Address	1-1 Iwasaku Karimata, Nagakute City, Aichi Prefecture
TEL	0561623311
Email	saito1023@aichi-med-u.ac.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Saitou
Organization	Aichi Medical University Hospital
Division name	obstetoric and gynecology
Zip code	480-1195
Address	1-1 Iwasaku Karimata, Nagakute City, Aichi Prefecture
TEL	0561623311
Homepage URL
Email	saito1023@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University Hospital
Institute
Department

Funding Source
Organization	no organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Aichi Medical University Hospital
Address	1-1 Yazako Karimata, Nagakute City, Aichi Prefecture
Tel	0561623311
Email	saito1023@aichi-med-u.ac.jp

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	2021 Year 10 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	Preinitiation
Date of protocol fixation	2020 Year 06 Month 08 Day
Date of IRB	2020 Year 08 Month 03 Day
Anticipated trial start date	2020 Year 08 Month 03 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry	2024 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 01 Day
Last modified on	2021 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052089