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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name