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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039378
Receipt No. R000044901
Scientific Title Effect of obstetric analgesia to reduce the postpartum depression
Date of disclosure of the study information 2020/02/03
Last modified on 2020/08/06

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Basic information
Public title Effect of obstetric analgesia to reduce the postpartum depression
Acronym Effect of obstetric analgesia to reduce the postpartum depression
Scientific Title Effect of obstetric analgesia to reduce the postpartum depression
Scientific Title:Acronym Effect of obstetric analgesia to reduce the postpartum depression
Region
Japan

Condition
Condition Pregnant women after 35 weeks gestation
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify whether postpartum depression is reduced in women who have received obstetric analgesia for delivery atSt.Luke's International Hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Edinburgh Postnatal Depression Scale(Postpartum period: 1 month, 3 months, 6 months, 1year after delivery)
Key secondary outcomes 1. Maternity blue questionnaire(1st day- 5th day after delivery)
2. Pain Scale(NRS)
3. Satisfaction of delivery

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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Pregnant women after 35 weeks gestation in St. Luke's International hospital.
Key exclusion criteria 1. pregnant women who can not answer a questionnaire.
2. pregnant women age under 20
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yasuko
Middle name
Last name Nagasaka
Organization St. Luke's International Hospital
Division name Anesthesia Department
Zip code 1048560
Address 9-1 Akashi-Cho, Chuo-ku, Tokyo, 104-8560, Japan
TEL +81-3-3541-5151
Email nagasaka@luke.ac.jp

Public contact
Name of contact person
1st name Nobuko
Middle name
Last name Fujita
Organization St.Luke's International Hospital
Division name Anesthesia Department
Zip code 104-8560
Address 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL 03-3541-5151
Homepage URL
Email nobukofu@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

Funding Source
Organization Funding; Departmental
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Luke's International Hospital
Address 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel 81-3-3541-5151
Email kenkyukikaku@luke.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 聖路加国際病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 03 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 19 Day
Date of IRB
2019 Year 11 Month 20 Day
Anticipated trial start date
2020 Year 06 Month 12 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective, observational, cohort study

Management information
Registered date
2020 Year 02 Month 03 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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