UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028772 |
|---|---|
| Receipt number | R000032925 |
| Scientific Title | The elucidation of placental origins of pregnancy disorders. |
| Date of disclosure of the study information | 2017/08/22 |
| Last modified on | 2019/08/26 15:51:18 |
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Basic information
Public title
The elucidation of placental origins of pregnancy disorders.
Acronym
The elucidation of pregnancy disorders.
Scientific Title
The elucidation of placental origins of pregnancy disorders.
Scientific Title:Acronym
The elucidation of pregnancy disorders.
Region
| Japan |
Condition
Condition
Fetal growth restriction and hypertensive pregnancy disorders
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate placental origin of pregnancy disorders.
Basic objectives2
Others
Basic objectives -Others
To investigate factors affecting maternal and infant outcomes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of expression of maternal serum protein and cell-free RNA between pregnant women complicated with and without placental origin of pregnancy disorders.
Key secondary outcomes
1. Pathological findings of the placenta.
2. Expression of maternal serum protein and cell-free RNA in the maternal blood.
3. Expression of protein and gene levels in the placenta.
4. Relationship between maternal blood concentration of tadalafil and urine concentration of cGMP.
5. Concentration of tadalafil in the cord blood.
6. Concentration of cGMP in the cord blood.
7. Relationship between maternal blood concentration of tadalafil and perinatal factors.
8. Relationship between concentration of tadalafil in the cord blood and perinatal factors.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Age>=20
2. Gestational age between 20 + 0 and 33 + 6 weeks in pregnant women.
3. The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2014) in pregnant women.
4. Singleton pregnancy.
5. Written informed consent.
Key exclusion criteria
Attending physician decides to entry inappropriate.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ikeda |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
tadafer.study@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Maki, Michiko Kubo, Hiroaki Tanaka, Takashi Umekawa |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
Homepage URL
tadafer.study@gmail.com
Sponsor or person
Institute
Mie university hospital, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 22 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The project staff are now collecting samples.
Management information
Registered date
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032925
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| Registered date | File name |
| Research case data | |
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