UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054603 |
|---|---|
| Receipt number | R000062388 |
| Scientific Title | The role of allopregnanolone in postpartum depression |
| Date of disclosure of the study information | 2024/06/13 |
| Last modified on | 2024/06/07 12:53:42 |
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Basic information
Public title
The role of allopregnanolone in postpartum depression
Acronym
The role of allopregnanolone in postpartum depression
Scientific Title
The role of allopregnanolone in postpartum depression
Scientific Title:Acronym
The role of allopregnanolone in 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 investigate whether allopregnanolone, a progesterone metabolite, is decreased in Japanese patients with postpartum depression.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the role on pathological conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum concentrations of progesterone metabolites (pregnenolone, progesterone, 5alpha-dihydroprogesterone, allopregnanolone) at late pregnancy (around 36 weeks of pregnancy), immediately after delivery (3-6 days after delivery), 3 months and 5 months after delivery, when postpartum depression is most likely to occur.
Edinburgh Postnatal Depression Questionnaire(EPDS), Athens Insomnia Scale(AIS), and Brief-type self-administered diet history questionnaire (BDHQ) at the same time points.
Key secondary outcomes
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
Those who are already participating in research on postpartum hair loss.
Those who have given informed consent.
Key exclusion criteria
Those who do not consent to informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-5322
a-kacrm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Hirose |
Organization
Tokyo Medical and Dental University
Division name
Department of Obstetrics and Gynecology
Zip code
113-8510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-5322
Homepage URL
a-kacrm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Asuka Hirose
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo, Tokyo
Tel
03-5803-5322
a-kacrm@tmd.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
| 2024 | Year | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We provide explanations using a written consent document to the participants of the ``Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss'' study, which has been ongoing since 2023, and informed consent is obtained.
We use blood samples and information collected in the aforementioned study.
Information includes age, parity, body composition, past history, current medical history, occupational history, lifestyle, infertility treatment, delivery method (vaginal delivery/cesarean section), amount of blood loss during delivery, pregnancy complications, menstrual history, child feeding method (breastfeeding/artificial feeding/mixed feeding), and weaning period.
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062388
