UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	yuuto.m78@gmail.com

Sponsor
Institute	Department of Preventive Services, Kyoto University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050448