UMIN-CTR Clinical Trial

Basic information
Public title	Two weeks online postpartum check is effective for maternal mental health
Acronym	Two weeks online postpartum check is effective for maternal mental health
Scientific Title	Effectiveness of two weeks online postpartum check for maternal mental health
Scientific Title:Acronym	Effectiveness of two weeks online postpartum check for maternal mental health
Region	Japan

Condition
Condition	Postpartum depression
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. two weeks postpartum check (both face to face and online) for maternal mental health is effective to find and prevent postpartum depression. 2. both online and face to face postpartum check is effective.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	compare EPDS with groupA (two weeks postpartum check perfomed) and groupB (without two weeks postpartum check)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	2weeks online postpartum check 1month postpartum check
Interventions/Control_2	2weeks face to face postpartum check 1month postpartum check
Interventions/Control_3	No 2weeks postpartum check 1month postpartum check only
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	postpartum check done in same place with delivery hospital
Key exclusion criteria	no postpartum check done after delivery hospital
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Nobuko Middle name Last name Nishioka
Organization	Koshigaya Municipal Hospital
Division name	Obstetrics and Gynecology
Zip code	343-0023
Address	10-32 HigashiKoshigaya Koshigaya City Saitama
TEL	048-965-2221
Email	nobunsok@nifty.com

Public contact
Name of contact person	1st name Nobuko Middle name Last name Nishioka
Organization	Koshigaya Municipal Hospital
Division name	Obstetrics and Gynecology
Zip code	343-0023
Address	10-32 HigashiKoshigaya Koshigaya City Saitama
TEL	048-965-2221
Homepage URL
Email	nobunsok@nifty.com

Sponsor
Institute	Obstetrics and Gynecology Koshigaya Municipal Hospital
Institute
Department

Funding Source
Organization	Koshigaya Municipal Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saitama Medical University Saitama Medical Center Sakuragaoka Hospital Jichi Medical University Saitama Medical Center Kashiwazaki Ladies Clinic Makita Sanfujinka Maruyama Memorial General Hospital Hirata Clinic Fukaya Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Koshigaya Municipal Hospital
Address	10-32 HigashiKoshigaya Koshigaya City Saitama
Tel	048-965-2221
Email	nobunsok@nifty.com

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	2022 Year 01 Month 31 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	Enrolling by invitation
Date of protocol fixation	2021 Year 11 Month 16 Day
Date of IRB	2021 Year 11 Month 28 Day
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 29 Day
Last modified on	2022 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053072