UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051842 |
|---|---|
| Receipt number | R000059156 |
| Scientific Title | Elective management with power Doppler color score for retained products of conception |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2024/08/15 11:21:44 |
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Basic information
Public title
Elective management with power Doppler color score for retained products of conception
Acronym
RPOC management with PDCS
Scientific Title
Elective management with power Doppler color score for retained products of conception
Scientific Title:Acronym
RPOC management with PDCS
Region
| Japan |
Condition
Condition
retained products of conception
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of PDCS for RPOC management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of PDCS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
conservative management
Interventions/Control_2
Uterine artery embolism and/or hysteroscopic resection
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
Women diagnosed with retained products of conception wishing to preserve fertility.
Key exclusion criteria
Patients who did not give written concent, patients rejecting participation, and patients considered to be inappropriate by their attending physicians.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442261
tomonakamura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Nakamura |
Organization
Nagoya University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442261
Homepage URL
tomonakamura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya University Hospital Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442261
sentanjimu@med.nagoya-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
| 2023 | Year | 08 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment is currently under progress.
Management information
Registered date
| 2023 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059156
