UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037155 |
|---|---|
| Receipt number | R000042332 |
| Scientific Title | Nationwide research on management of inherited thrombophilia in pregnancy |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2023/01/12 17:46:09 |
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Basic information
Public title
Nationwide research on management of inherited thrombophilia in pregnancy
Acronym
MITP study
Scientific Title
Nationwide research on management of inherited thrombophilia in pregnancy
Scientific Title:Acronym
MITP study
Region
| Japan |
Condition
Condition
pregnant women with inherited thormbophilia
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the actual condition of pregnancy and delivery management of patients with inherited thrombophilia in the present Japan, and grasping the management method, in order to formulate the medical treatment guideline on pregnancy and delivery management of inherited thrombophilia.
Basic objectives2
Others
Basic objectives -Others
Calculate the number of deliveries for 5 years in the target facilities, the number of complications with inherited thrombophilia, the number of cases by three types of inherited thrombophilia by year, diagnostic methods, levels of activity and antigen, and the number of gene diagnoses
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Matters concerning pregnancy and delivery cases of inherited thrombophilia in the research facilities:
1.The number of five-year deliveries from January 1, 2014 to December 31, 2018.
2. Presence of pregnancy complications of inherited thrombophilia.
3. The number of cases according to type of inherited thrombophilia by year.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Perinatal registration facility of the Japanese Society of Obstetrics and Gynecology which is likely to manage pregnancy and delivery of patients with hereditary thrombophilia.
Key exclusion criteria
No exclusion criteria
Target sample size
415
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Kobayashi |
Organization
Hamamatsu Medical Center
Division name
Obstetrics and Gynecology
Zip code
432-8580
Address
328 Tomizuka-cho, Naka-ku, Hamamatsu, Shizuoka
TEL
053-453-7111
tkoba@hmedc.or.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kobayashi |
Organization
Hamamatsu Medical Center
Division name
Obstetrics and Gynecology
Zip code
432-8580
Address
328 Tomizuka-cho, Naka-ku, Hamamatsu, Shizuoka
TEL
053-453-7111
Homepage URL
tkoba@hmedc.or.jp
Sponsor or person
Institute
Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Kanazawa Univeristy, Medical Ethics Review Board
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2100
t-isomu@adm.kanazawa-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
| 2019 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042332
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s12185-022-03354-4
Number of participants that the trial has enrolled
594
Results
AT,PC,PS deficiency were observed in 84,67,443 pregnancies,respectively,with incidence rates among total deliveries at 0.012%,0.009%,0.061%. The percentage of institutions that measured both antigens and AT,PC,PS activity for the diagnosis of thrombophilia was 50.2%,46.9% of institutions did not perform gene analysis. Prophylactic anticoagulation therapy was used in the ante- and postpartum management of patients with AT deficiency at 67.1% and 66.3%.
Results date posted
| 2023 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pregnant women with hereditary thrombophilia
Participant flow
Not in particular because of retrospective surveillance
Adverse events
Not in particular
Outcome measures
Number of pregnancies and deliveries of patients with thrombophilia
The diagnosis of thrombophilia during pregnancy
Current peripartum management of patients with thrombophilia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation test
Management information
Registered date
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042332
