UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004233
Receipt number R000005089
Scientific Title Maternal endothelial function as a marker for predicting preeclampsia
Date of disclosure of the study information 2010/09/27
Last modified on 2012/09/27 09:20:52

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Basic information

Public title

Maternal endothelial function as a marker for predicting preeclampsia

Acronym

Predictive markers of preeclampsia

Scientific Title

Maternal endothelial function as a marker for predicting preeclampsia

Scientific Title:Acronym

Predictive markers of preeclampsia

Region

Japan


Condition

Condition

pregnant women at high risk of preeclampsia

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this study is to clarify the efficacy of Endo-PAT, a noninvasive endothelial function assessment device, as a predictive marker of preeclampsia in comparison with the other recognized markers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The occurrence of preeclampsia

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

Age>40
Family history of hypertension or NIDDM, and preeclampsia
Pregnancy complicated with DM, hypertension, kidney disorder, and autoimmune disorders
Obesity (BMI>30)
Previous history of preeclampsia
A twin or multiple pregnancy

Key exclusion criteria

Patients suffering from hemorrhage (e.g., hemophilia, and capillary fragility)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuo Konishi

Organization

Kyoto University Graduate School of Medicine

Division name

Gynecology and Obstetrics

Zip code


Address

54 Shogoin Kawahara-cho Sakyo-ku, Kyoto 606-8507, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto University Graduate School of Medicine

Division name

Gynecology and Obstetrics

Zip code


Address


TEL

075-751-3269

Homepage URL


Email



Sponsor or person

Institute

Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science & Technology

Organization

Division

Category of Funding Organization

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

2010 Year 09 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

Completed

Date of protocol fixation

2010 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry

2012 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2012 Year 06 Month 01 Day


Other

Other related information

Prospective study
Receiver operating characteristic analysis for evaluating predictive markers of preeclampsia using RH-PAT index, and maternal blood concentration of sFlt-1, Endoglin, PlGF, inhibin A, and activin A collected at 1st, 2nd and 3rd trimeter.


Management information

Registered date

2010 Year 09 Month 19 Day

Last modified on

2012 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005089


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name