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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014051 |
Receipt No. | R000016358 |
Scientific Title | Investigation about transition of placental blood flow in conservative management of placenta accreta |
Date of disclosure of the study information | 2014/07/01 |
Last modified on | 2017/03/28 |
Basic information | ||
Public title | Investigation about transition of placental blood flow in conservative management of placenta accreta | |
Acronym | Investigation about transition of placental blood flow in conservative management of placenta accreta | |
Scientific Title | Investigation about transition of placental blood flow in conservative management of placenta accreta | |
Scientific Title:Acronym | Investigation about transition of placental blood flow in conservative management of placenta accreta | |
Region |
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Condition | ||
Condition | placenta accreta | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The objectives of this research are investigation of placental blood flow and its evaluation methods in conservative management of placenta accreta, and verification of efficacy and safety of conservative management. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | volume of placental blood flow
serum hCG |
Key secondary outcomes |
Base | |
Study type |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Evaluation of placental blood flow by color doppler ultrasonography
Evaluation of volume of placental blood flow by magnetic resonance imaging Measurement of serum hCG |
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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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | The patients who were diagnosed with placenta accreta and recieved conservative management. | |||
Key exclusion criteria | none | |||
Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 54 Shogoin Kawahara-cho, Sakyo, Kyoto,606-8507, Japan | ||||||
TEL | 075-751-3269 | ||||||
konishi@kuhp.kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyoto University Graduate School of Medicine | ||||||
Division name | Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 54 Shogoin Kawahara-cho, Sakyo, Kyoto,606-8507, Japan | ||||||
TEL | 075-751-3269 | ||||||
Homepage URL | |||||||
kkaoru@kuhp.kyoto-u.ac.jp |
Sponsor | |
Institute | Kyoto University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Kyoto University Graduate School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016358 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |