UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048272 |
|---|---|
| Receipt number | R000055010 |
| Scientific Title | Effectiveness of point of care testing (POCT) devices for postpartum hemorrhage: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2025/07/06 09:46:13 |
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Basic information
Public title
Effectiveness of point of care testing (POCT) devices for postpartum hemorrhage: A systematic review and meta-analysis
Acronym
Investigation of the usefulness of POCT devices in postpartum hemorrhage
Scientific Title
Effectiveness of point of care testing (POCT) devices for postpartum hemorrhage: A systematic review and meta-analysis
Scientific Title:Acronym
Investigation of the usefulness of POCT devices in postpartum hemorrhage
Region
| Japan |
Condition
Condition
postpartum hemorrhage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a systematic review of the literature on the use and efficacy of POCT devices in postpartum hemorrhage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) for hypofibrinogenemia
Key secondary outcomes
Correlation with fibrinogen values measured by conventional methods such as the Clauss method (correlation coefficient, coefficient of determination)
Base
Study type
Others,meta-analysis etc
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
[inclusion Criteria for study]
1. Literature in English
2. Studies on human subjects
[Selection Criteria for Eligible Patients]
nothing
Key exclusion criteria
[Exclusion Criteria for Studies]
1. Literature written in languages other than English
2. Research on animals
3. Research that has not been published, such as abstracts of academic conferences and clinical trial protocols
[Exclusion criteria for eligible patients]
1. Pregnant women with obvious congenital coagulopathy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Eishin |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University
Division name
Department of Health Data Science, Graduate School of Data Science
Zip code
236-0027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa
TEL
81-45-787-2311
einaka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Eishin |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University
Division name
Department of Health Data Science, Graduate School of Data Science
Zip code
236-0027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa
TEL
81-45-787-2311
Homepage URL
einaka@saitama-med.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self-financing of funds
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
Yokohama City University
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa
Tel
81-45-787-2311
einaka@saitama-med.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
横浜市立大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2023.06.11.23291255v1
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S004938482500088X
Number of participants that the trial has enrolled
2902
Results
A total of 9 papers (16 studies, 2,902 patients) were analyzed, and POCT for postpartum bleeding patients showed good diagnostic accuracy for hypofibrinogenemia.
Results date posted
| 2025 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with postpartum hemorrhage with total blood loss of 1000 ml or more after 20 weeks of pregnancy
Participant flow
Registration in electronic databases
Adverse events
NA
Outcome measures
Hypofibrinogenemia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 01 | Day |
Other
Other related information
This study will be a systematic review and meta-analysis.
Studies will be conducted in accordance with the PRISMA Statement and the Cochrane Handbook.
The electronic databases to be used for the search will be MEDLINE, Embase, CENTRAL, Cochrane database, and Web of Science.
Management information
Registered date
| 2022 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055010
