UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050591 |
|---|---|
| Receipt number | R000057621 |
| Scientific Title | Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/06/07 13:05:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss
Acronym
Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss
Scientific Title
Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss
Scientific Title:Acronym
Objective evaluation of postpartum hair loss and investigation of factors affecting the amount of hair loss
Region
| Japan |
Condition
Condition
Postpartum hair loss
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively evaluate the severity of postpartum hair loss, and examine the factors affecting the amount of hair loss.
Basic objectives2
Others
Basic objectives -Others
Postpartum hair loss is a well-known phenomenon, but there are few studies that have objectively evaluated the severity of hair loss. This research aims at the following three points. 1. To objectively evaluate the severity of postpartum hair loss. 2. To examine the factors affecting the amount of hair loss. 3. To investigate the effects of postpartum hair loss on psychological symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hair number and hair cycle using dermoscope
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
Pregnant women who are planning to deliver at Tokyo Medical and Dental University Hospital and are less than 24 weeks.
Key exclusion criteria
Pregnant women who cannot obtain informed consent. Those who have a history of alopecia before pregnancy.
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
Funding Source
Organization
Hoyu Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2023 | Year | 04 | Month | 01 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When participating in the study, participants will be asked to select Course A (no shaving/hair cycle test, scheduled for 40 people) or Course B (with shaving/hair cycle test, scheduled for 10 people).
1.Using a dermoscope, the number of hairs per 1cm2 of the scalp is examined at four locations: the parietal region, the occipital region, and both sides of the temporal region at 6 points in the second trimester and third trimester of pregnancy, immediately after delivery, 3 months, 5 months, and 1 year after delivery.
2.Blood tests will be performed at the same 6 time points. Complete blood count, estrogen, progesterone, testosterone, free testosterone, androstenedione, prolactin, oxytocin, thyroid hormone, cortisol, growth hormone are measured.
3.We investigate the following as they may affect hair loss: stress during childbirth (delivery method and amount of blood loss), age, body composition, medical history, pregnancy complications, lifestyle habits, and eating habits.
4.We will investigate the subjective evaluation of postpartum hair loss. The Edinburgh Postnatal Depression Scale and the Athens Insomnia Scale will also be investigated.
5.Women who choose course B are checked the hair cycle. 1.8 cm2 of scalp on the back of the head is shaved with a shaver and 1 cm2 is observed with a dermoscope. After 2-3 days, the hair is observed again to determine whether it is in the anagen phase (hair growing) or resting phase (hair not growing).
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | 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=R000057621
