UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041611
Receipt number R000047500
Scientific Title Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial
Date of disclosure of the study information 2020/08/31
Last modified on 2023/09/02 11:00:03

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Basic information

Public title

Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial

Acronym

Yokohama online medical consultation study

Scientific Title

Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial

Scientific Title:Acronym

Yokohama online medical consultation study

Region

Japan


Condition

Condition

Postpartum depression

Classification by specialty

Obstetrics and Gynecology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether providing an online medical consultation service to pregnant women can reduce the risk of postpartum depression.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Edinburgh Postnatal Depression Scale at 3-month postpartum

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The telehealth consultation service "Obstetrics and Gynecology Online/Pediatrics Online" allows for telemedicine consultations with gynecologists, pediatricians, and midwives in the evenings on weekdays, as well as consultations with midwives during the day on weekdays, as many times as needed, from the time of participation in the study until four months postpartum.

Interventions/Control_2

Information only

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

All pregnant women living in Yokohama City.

Key exclusion criteria

Consent to participate in the study cannot be obtained.
The subject is unable to communicate in Japanese.

Target sample size

720


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Hashimoto

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Departments of Health and Social Behavior

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3512

Email

hidehashimoto-circ@umin.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Arakawa

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Departments of Health and Social Behavior

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-3512

Homepage URL


Email

yukiara@m.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Yokohama city

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yokohama city

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2020 Year 08 Month 31 Day


Related information

URL releasing protocol

https://doi.org/10.1186/s12916-023-02918-3

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1186/s12916-023-02918-3

Number of participants that the trial has enrolled

734

Results

Three months post-delivery, women in the mHealth group had a lower risk of elevated postpartum depressive symptoms (47/310 [15.2%]) compared to the usual care group (75/329 [22.8%], risk ratio: 0.67 [95% confidence interval: 0.48-0.93]).

Results date posted

2023 Year 09 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Pregnant women living in Yokohama city

Participant flow

The participants were randomized to either the mHealth group or the usual care group and followed until three months post-delivery.

Adverse events

None

Outcome measures

The risk of elevated postpartum depressive symptoms

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 02 Month 28 Day

Date of IRB

2020 Year 03 Month 16 Day

Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2022 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 31 Day

Last modified on

2023 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name