UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023551 |
|---|---|
| Receipt number | 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 09:33:37 |
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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
| Obstetrics 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
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
D15017@hama-med.ac.jp
Sponsor or person
Institute
Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026971
