UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048160 |
|---|---|
| Receipt number | R000054883 |
| Scientific Title | A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM) |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2023/07/04 10:30:29 |
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Basic information
Public title
A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)
Acronym
A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)
Scientific Title
A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)
Scientific Title:Acronym
A prospective study on blood coagulation and fibrinolysis in the peripartum period using rotational thromboelastometry (ROTEM)
Region
| Japan |
Condition
Condition
pregnancy and postpartum period
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of blood coagulation and fibrinolysis of pregnant women in the third trimester, before the onset of labor (before and after 37 weeks gestation) , during the labor, and after delivery, using Rotational thromboelastometry (ROTEM).
Basic objectives2
Others
Basic objectives -Others
To evaluate viscoelastically coagulation and fibrinolysis function in the peripartum period.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The parameters of ROTEM assays
(CT, CFT, alpha, A10, MCF, LI30, LI60 in NATEM, EXTEM, FIBTEM, and APTEM assays)
Key secondary outcomes
1) Hemoglobin concentration, hematocrit, platelet count, prothrombin time, activated partial thromboplastin time, fibrinogen level, prothrombin fragment 1+2, plasmin alpha2-plasmin inhibitor complex, D-dimer
2) Correlation between ROTEM assays and coagulation/fibrinolysis parameters
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Singleton pregnancy women in the third trimester (from 28 to 40 weeks of pregnancy) who are expected vaginal delivery or cesarean section.
1. Pregnant women before the onset of labor (before and after 37 weeks of gestation)
2. Pregnant women during the labor
3. Postpartum women on day 1 postpartum
Key exclusion criteria
1. Patients medicated with antiplatelets or anticoagulants.
2. Patients who have venous thromboembolism.
3. Patients with postpartum hemorrhage during delivery (in vaginal delivery >= 800 mL, in cesarean section >= 1500 mL).
4. Patients complicated with disease involving platelets, coagulation, fibrinolysis, anticoagulation, or antifibrinolysis system.
5. Patients with anemia (hemoglobin concentration <8.0 g/dL) before the delivery.
6. Patients with severe liver disease (or AST >= 100 U/L).
7. Patients with severe renal disease (or serum creatinine >= 1.3 mg/dL).
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Itoh |
Organization
Hamamatsu University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2309
ihiroaki@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Fukuchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2309
Homepage URL
cfukuchi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University Scool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel
053-435-2680
rinri@hama-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation on the changes of blood coagulation and fibrinolysis of pregnant women in the third trimester, before the onset of labor, during the labor, and after delivery, using Rotational thromboelastometry (ROTEM)
Management information
Registered date
| 2022 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054883
