UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042510 |
|---|---|
| Receipt number | R000048103 |
| Scientific Title | Questionnaire study on postpartum alopecia |
| Date of disclosure of the study information | 2020/11/21 |
| Last modified on | 2024/11/25 13:34:39 |
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Basic information
Public title
Questionnaire study on hair loss in postpartum women
Acronym
Questionnaire study on hair loss in postpartum women
Scientific Title
Questionnaire study on postpartum alopecia
Scientific Title:Acronym
Questionnaire study on postpartum alopecia
Region
| Japan |
Condition
Condition
Postpartum alopecia
Classification by specialty
| Obstetrics and Gynecology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the frequency, timing, and exacerbating factors of postpartum alopecia.
Basic objectives2
Others
Basic objectives -Others
We investigate the psychological effects of postpartum hair loss.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and timing of postpartum alopecia.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who delivered at our hospital 10-18 months ago.
Key exclusion criteria
Not applicable
Target sample size
340
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
Tokyo Medical and Dental 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
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
| 2020 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC10846762/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC10846762/
Number of participants that the trial has enrolled
331
Results
A total of 331(21.0%) responses were analyzed; among these 304(91.8%) women had postpartum hair loss.The average time for the start, peak, and end of hair loss was 2.9, 5.1, and 8.1 months, respectively.Logistical regression analyses revealed that longer-term breastfeeding and preterm labor were independent predictors of postpartum hair loss.
Results date posted
| 2024 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
aaa
Participant flow
aaa
Adverse events
None
Outcome measures
In the questionnaire, the following questions were asked to assess the baseline characteristics: age at delivery, pregnancy and delivery history, height, prepregnancy weight, existing diseases, fertility treatments, current menstrual status, days from delivery to the resumption of menstruation, and smoking and alcohol intake before pregnancy and after delivery. Regarding pregnancy, delivery, and child care, we asked the following questions: delivery week, delivery method (vaginal delivery/elective cesarean section/emergency cesarean section), blood transfusion during labor, infant weight, abnormalities during labor, presence or absence of preterm labor, gestational diabetes mellitus, and hypertensive disorders of pregnancy, infant feeding at 3 months after delivery (breastfeeding/mixed feeding/formula feeding), and the duration of breastfeeding.
For postpartum hair loss, we first inquired about the extent of hair loss using a 4-point Likert scale (not at all, a little, quite a lot, very much). Furthermore, except for those who had no hair loss, the following questions were asked: start, peak, and end time of hair loss; whether they felt anxious or stressed about their hair loss (not at all, a little, quite a lot, very much); when they noticed their hair loss; whether they took any remedial action for their hair loss; and whether they talked to someone about their worries.
Sleep disorder was evaluated using the Athens insomnia scale (AIS), which was developed as a brief and easy-to-administer questionnaire for determining the severity of insomnia defined according to the International Classification of Disease Tenth Revision. Depressive symptoms were assessed using the Edinburgh postnatal depression scale (EPDS). The EPDS, originally developed in the United Kingdom in 1987, is a 10-item self-report measure designed to screen women for symptoms of emotional distress during the postpartum period using a 4-point Likert scale. EPDS was translated into Japanese in 1996, and its reliability and validity have been confirmed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 01 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048103
