UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013900
Receipt number R000016206
Scientific Title Outcome of pregnancy women exhibit a reduced antithrombin activity
Date of disclosure of the study information 2014/05/10
Last modified on 2018/11/26 15:01:18

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Basic information

Public title

Outcome of pregnancy women exhibit a reduced antithrombin activity

Acronym

Outcome of pregnancy with PIATD

Scientific Title

Outcome of pregnancy women exhibit a reduced antithrombin activity

Scientific Title:Acronym

Outcome of pregnancy with PIATD

Region

Japan


Condition

Condition

The pregnancy women exhibit a reduced antithrombin activity

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This prospective study was performed to characterize
the outcome of pregnancy women exhibit a reduced antithrombin activity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The risk of pregnancy-induced hypertension and HELLP syndrome, the frequency of abnormalities in blood examination.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

After receiving a full explanation upon participation in this study, patients with documented consent was obtained

Key exclusion criteria

Patients principal investigator was deemed inappropriate as a subject

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisanori Minakami

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Obstetrics

Zip code


Address

Kita-ku N15 W7, Sapporo 060-8638, Japan

TEL

011-706-6051

Email

minasho@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mamoru Morikawa

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Obstetrics

Zip code


Address

Kita-ku N15 W7, Sapporo 060-8638, Japan

TEL

011-706-6051

Homepage URL


Email

mmamoru@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Obstetrics, Hokkaido University Graduate School of Medicine

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


Address


Tel


Email



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

2014 Year 05 Month 10 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

Completed

Date of protocol fixation

2014 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We observe the patients according to the following, Guidelines for obstetrical practice in Japan: Japan Society of Obstetrics and Gynecology (JSOG) and Japan Association of Obstetricians and Gynecologists (JAOG) 2011 edition. Minakami H, et. al. ; Japan Society of Obstetrics and Gynecology; Japan Association of Obstetricians and Gynecologists. J Obstet Gynaecol Res. 2011 Sep;37(9):1174-97


Management information

Registered date

2014 Year 05 Month 07 Day

Last modified on

2018 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016206


Research Plan
Registered date File name
2016/09/09 [No.013-0144]【140130承認】.zip

Research case data specifications
Registered date File name
2016/09/09 ■PIATD妊婦研究 調査票.fmp12

Research case data
Registered date File name
2016/09/09 ■PIATD妊婦研究 調査票 5施設統合.fmp12