UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022367
Receipt number R000025609
Scientific Title The association between postpartum depression and oxidative stress during and after pregnancy
Date of disclosure of the study information 2016/05/20
Last modified on 2019/11/21 22:57:46

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Basic information

Public title

The association between postpartum depression and oxidative stress during and after pregnancy

Acronym

The association between postpartum depression and oxidative stress during and after pregnancy

Scientific Title

The association between postpartum depression and oxidative stress during and after pregnancy

Scientific Title:Acronym

The association between postpartum depression and oxidative stress during and after pregnancy

Region

Japan


Condition

Condition

postpartum depression

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the association between postpartum depression and oxidative stress during and after pregnancy and other background factors

Basic objectives2

Others

Basic objectives -Others

To investigate the prevention and ealy detection of postpartum depression

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

serum and urinary oxidative stress markers

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

16 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

Pregnant women under 24 weeks

Key exclusion criteria

Women who denied written informed consent

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Asuka
Middle name
Last name Hirose

Organization

Tokyo Medical and Dental University

Division name

Department of Obstetrics and Gynecology

Zip code

1138510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-5322

Email

a-kacrm@tmd.ac.jp


Public contact

Name of contact person

1st name Asuka
Middle name
Last name Hirose

Organization

Tokyo Medical and Dental University

Division name

Department of Obstetrics and Gynecology

Zip code

113-8510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-5322

Homepage URL


Email

a-kacrm@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

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

Tokyo Medical and Dental University

Address

Yushima 1-5-45, Bunkyo, Tokyo

Tel

03-5803-5322

Email

a-kacrm@tmd.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

2016 Year 05 Month 20 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 05 Month 19 Day

Date of IRB

2016 Year 06 Month 30 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name