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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023551
Receipt No. R000026971
Scientific Title Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Date of disclosure of the study information 2016/08/08
Last modified on 2018/02/08

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Basic information
Public title Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Acronym Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Scientific Title Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Scientific Title:Acronym Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Region
Japan

Condition
Condition Preterm delivery
Placental abruption
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of plasminogen activator inhibitor type 1 in mid-term pregnancy for the prediction of preterm delivery or placental abruption
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of preterm delivery
Key secondary outcomes The frequency of placental abruption

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Pregnant women between 24th and 27th week of gestation whose blood will be collected for mid-term examination
Key exclusion criteria Pregnant induced hypertension
Multiple pregnancy
Gestational diabetes mellitus
Diabetes mellitus
Severe bacterial infection
Fetal anomaly
The case whose blood was collected in the afternoon
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Itoh
Organization Hamamatsu University Hospital
Division name Perinatal Center
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2309
Email hitou-endo@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Oda
Organization Hamamatsu University School of Medicine
Division name Obstetrics & Gynecology
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2309
Homepage URL
Email D15017@hama-med.ac.jp

Sponsor
Institute Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization No funding source
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
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 浜松医科大学附属病院(静岡県)/Hamamatsu University Hospital
富士市立中央病院(静岡県)/Fuji City General Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 08 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
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation of the date of delivery among pregnant women whose blood was collected in mid-term of pregnancy

Management information
Registered date
2016 Year 08 Month 08 Day
Last modified on
2018 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026971

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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