UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039378 |
|---|---|
| Receipt number | 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 | 2023/12/12 13:42:31 |
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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
| Obstetrics 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
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
nobukofu@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
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
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
| 2024 | Year | 12 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044901
