UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023551
Receipt number R000026971
Scientific Title Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage
Date of disclosure of the study information 2016/08/08
Last modified on 2018/02/08 09:33:37

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Basic information

Public title

Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage

Acronym

Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage

Scientific Title

Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage

Scientific Title:Acronym

Research on pathophysiology and prediction of placental abruption and subchorionic hemorrhage

Region

Japan


Condition

Condition

Preterm delivery
Placental abruption

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of plasminogen activator inhibitor type 1 in mid-term pregnancy for the prediction of preterm delivery or placental abruption

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The frequency of preterm delivery

Key secondary outcomes

The frequency of placental abruption


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

Pregnant women between 24th and 27th week of gestation whose blood will be collected for mid-term examination

Key exclusion criteria

Pregnant induced hypertension
Multiple pregnancy
Gestational diabetes mellitus
Diabetes mellitus
Severe bacterial infection
Fetal anomaly
The case whose blood was collected in the afternoon

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Itoh

Organization

Hamamatsu University Hospital

Division name

Perinatal Center

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka

TEL

053-435-2309

Email

hitou-endo@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoaki Oda

Organization

Hamamatsu University School of Medicine

Division name

Obstetrics & Gynecology

Zip code


Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka

TEL

053-435-2309

Homepage URL


Email

D15017@hama-med.ac.jp


Sponsor or person

Institute

Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

No funding source

Organization

Division

Category of Funding Organization

Other

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

浜松医科大学附属病院(静岡県)/Hamamatsu University Hospital
富士市立中央病院(静岡県)/Fuji City General Hospital


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 08 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

2016 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 08 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

Observation of the date of delivery among pregnant women whose blood was collected in mid-term of pregnancy


Management information

Registered date

2016 Year 08 Month 08 Day

Last modified on

2018 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name