UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032042 |
|---|---|
| Receipt number | R000036546 |
| Scientific Title | The effect of labor analgesia on the prevalence of postpartum depression |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2018/04/02 19:53:11 |
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Basic information
Public title
The effect of labor analgesia on the prevalence of postpartum depression
Acronym
Labor analgesia and postpartum depression
Scientific Title
The effect of labor analgesia on the prevalence of postpartum depression
Scientific Title:Acronym
Labor analgesia and postpartum depression
Region
| Japan |
Condition
Condition
postpartum depression
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify whether postpartum depression is reduced in women who have experienced labor analgesia during delivery.
Basic objectives2
Others
Basic objectives -Others
To identify the correlation with labor analgesia and labor pain and labor satifaction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify whether postpartum depression is reduced in women who have received labor analgesia during delivery by analyzing Edinburgh Postnatal Depression Scale scores before and after delivery.
Key secondary outcomes
To identify the impacts of labor analgesia on postpartum pain and labor satisfaction
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 over 35 weeks due who are planned to go through delivery at St. Luke's International Hospital
Key exclusion criteria
1.Cannot fill out the questionnaire due to mental or linguistic disability
2.Is known of a mental disease
3.Is known of fetal disorder
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Nagasaka |
Organization
St.Luke's International Hospital
Division name
Department of Anesthesia
Zip code
Address
9-1 Akashi-cho, Chuo-ku Tokyo
TEL
03-3541-5151
nagasaka@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Nagasaka |
Organization
St. Luke's International Hospital
Division name
Department of Anesthesia
Zip code
Address
9-1 Akashi-cho, Chuo-ku Tokyo
TEL
03-3541-5151
Homepage URL
nagasaka@luke.ac.jp
Sponsor or person
Institute
St.Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Luke's International 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
Address
Tel
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
| 2018 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036546
