UMIN-CTR Clinical Trial

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

Postpartum hair loss

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Hair number and hair cycle using dermoscope

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

a-kacrm@tmd.ac.jp

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

Email

a-kacrm@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Hoyu Science Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Medical and Dental University

Address

Yushima 1-5-45, Bunkyo, Tokyo

Tel

03-5803-5322

Email

a-kacrm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

03

Month

01

Day

Date of IRB

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 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).

Registered date

2023

Year

03

Month

15

Day

Last modified on

2023

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057621