UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044230 |
|---|---|
| Receipt number | R000050448 |
| Scientific Title | Prognostic accuracy of shock index for severe postpartum hemorrhage in high-income country: Protocol for a systematic review and meta-analysis |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2022/11/03 10:01:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prognostic accuracy of shock index for severe postpartum hemorrhage in high-income country: Protocol for a systematic review and meta-analysis
Acronym
Prognostic accuracy of shock index for severe postpartum hemorrhage in high-income country: Protocol for a systematic review and meta-analysis
Scientific Title
Prognostic accuracy of shock index for severe postpartum hemorrhage in high-income country: Protocol for a systematic review and meta-analysis
Scientific Title:Acronym
Prognostic accuracy of shock index for severe postpartum hemorrhage in high-income country: Protocol for a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Postpartum hemorrhage (PPH)
Classification by specialty
| Obstetrics and Gynecology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this review is to conduct a systematic review and meta-analysis of relevant studies based on a rigorous methodology and to assess the prognostic value of shock index for prediction of severe PPH requiring higher-level care in high-income countries.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We will assess severe PPH required higher-level care as a primary outcome for a meta-analysis. It is defined as the need for use of blood products, interventional radiology, laparotomy (other than cesarean section), or admission to intensive care unit (ICU).
Key secondary outcomes
We will also assess a blood loss of 1000 ml or more within 24 hours after birth as a secondary outcome for a meta-analysis.
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
1 women in the peripartum period
2 studies in high-income countries defined by World Bank Country and Lending Groups
3 studies evaluating the incidence of severe PPH or the adverse events associated with PPH
Key exclusion criteria
studies reporting insufficient data for constructing a two by two table.
We will also exclude case reports and diagnostic case control studies.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Makino |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2426
yuuto.m78@gmail.com
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Makino |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2426
Homepage URL
yuuto.m78@gmail.com
Sponsor or person
Institute
Department of Preventive Services,
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
not applicable
Address
not applicable
Tel
not applicable
not applicable
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
| 2021 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.15292
Publication of results
Published
Result
URL related to results and publications
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.15292
Number of participants that the trial has enrolled
9
Results
Nine studies were included after the eligibility assessment. All studies were considered to either have a high risk of bias or high applicability concerns. The sensitivity of the four studies that defined severe PPH as PPH requiring blood transfusion ranged from 0.51 to 0.80, whereas their specificity ranged from 0.33 to 0.92.
Results date posted
| 2022 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 10 | Month | 10 | Day |
Other
Other related information
Protocol registered in medRxiv (https://www.medrxiv.org/)
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050448
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
