UMIN-ICDS Clinical Trial

Public title

A multi-panel questionnaire study on maternal and child health promotion for low birthrate prevention

Acronym

A multi-panel questionnaire study on maternal and child health promotion for low birthrate prevention

Scientific Title

A multi-panel questionnaire study on maternal and child health promotion for low birthrate prevention

Scientific Title:Acronym

A multi-panel questionnaire study on maternal and child health promotion for low birthrate prevention

Region

Japan

Condition

Thinning of uterine scars following cesarean section, back/ pelvic pain through perinatal to postpartum period

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objectives of this study are to understand true states of thinning of uterine scars following cesarean section and back/pelvic pain through perinatal to postpartum period, to extract the issues of current Japanese preventive health system for parturient/puerperant, and to analyze the changes of mental and physical condition through perinatal to postpartum period from the view point of parturient/puerperant and her physician in charge.

Basic objectives2

Others

Basic objectives -Others

Perceptions, views, and experience in cesarean section, back and pelvic pain, and postpartum care in general, etc.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

(1) A panel of Japanese obstetricians and gynecologists
Perceptions, views, experiences, etc. regarding cesarean section, back/ pelvic pain, and postpartum care in general
(2) A panel of Japanese parous women
Conditions, feelings, information, views, etc. based on past childbirth experiences
(3) A panel of pregnant women planed cesarean section
Real-time status, feelings, information, views, etc. at pre- and post- 3month of childbirth.
(4) A panel of the physicians in charge of pregnant women planed cesarean section
Perceptions, views, experiences, etc. in cesarean section
(5) A panel of pregnant women with back/ pelvic pain
Real-time status, feelings, information, views, etc. at pre-, during postpartum hospitalization and post- 4-8 weeks of childbirth.
(6) A panel of physicians in charge of pregnant women with back/ pelvic pain
Perceptions, views, and experiences of back/ pelvic pain and postpartum care in general

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)A panel of Japanese obstetricians and gynecologists
A member of "m3.com", who advocates obstetrics and gynecology and has at least one delivery per year at affiliated medical institution.
(2) A panel of Japanese parous women
A parous woman survey monitor member operated by Rakuten Insight, Inc.
(3) A panel of pregnant women planed cesarean section
A pregnant woman enrolled as research subjects in the "Observational Study of the Prevention of Cesarean Scar Syndrome after Cesarean Section Using Barbed Suture and Conventional Suture."
(4) A panel of the physicians in charge of pregnant women planed cesarean section
A physician in charge of pregnant women enrolled as research subjects in the "Observational Study of the Prevention of Cesarean Scar Syndrome after Cesarean Section Using Barbed Suture and Conventional Suture."
(5) A panel of pregnant women with back/ pelvic pain
A pregnant woman enrolled as research subjects in the "Prospective cohort observational study to investigate the effect of exercise guidance by a physical therapist to improve pain in women with pregnancy-related pelvic pain."
(6) A panel of physicians in charge of pregnant women with back/ pelvic pain
A physician in charge of pregnant women enrolled as research subjects in the "Prospective cohort observational study to investigate the effect of exercise guidance by physical therapists for the purpose of improving pain in women with pregnancy-related pelvic pain."

Key exclusion criteria

None

Target sample size

3030

Name of lead principal investigator

1st name	Daiju
Middle name
Last name	Ichimaru

Organization

M3,Inc.

Division name

e-Evidence Solution Company

Zip code

107-0052

Address

1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-6229-8921

Email

daiju-ichimaru@m3.com

Name of contact person

1st name	Daiju
Middle name
Last name	Ichimaru

Organization

M3, Inc.

Division name

e-Evidence Solution Company

Zip code

107-0052

Address

1-11-44 Akasaka, Minato-ku, Tokyo

TEL

03-6229-8921

Homepage URL

Email

daiju-ichimaru@m3.com

Institute

M3, Inc.

Institute

Department

Personal name

Organization

Secretariat for Regional Development, Cabinet Office, Government of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Conference of Clinical Research

Address

1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan

Tel

03-6868-7022

Email

jccr-info@jccr.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

08

Month

21

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

Completed

Date of protocol fixation

2023

Year

07

Month

10

Day

Date of IRB

2023

Year

07

Month

21

Day

Anticipated trial start date

2023

Year

08

Month

14

Day

Last follow-up date

2024

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design
Non-interventional, cohort study

Who is eligible to apply
(1) A panel of Japanese obstetricians and gynecologists(N=300)
A member of "m3.com", who advocates obstetrics and gynecology and has at least one delivery per year at affiliated medical institution.
(2) A panel of Japanese parous women (N=2,000)
A parous woman survey monitor member operated by Rakuten Insight, Inc.
(3) A panel of pregnant women planed cesarean section (N=400)
A pregnant woman enrolled as research subjects in the "Observational Study of the Prevention of Cesarean Scar Syndrome after Cesarean Section Using Barbed Suture and Conventional Suture."
(4) A panel of the physicians in charge of the subjects of (3) (N=160)
(5) A panel of pregnant women with back/ pelvic pain (N=120)
A pregnant woman enrolled as research subjects in the "Prospective cohort observational study to investigate the effect of exercise guidance by a physical therapist to improve pain in women with pregnancy-related pelvic pain."
(6) A panel of physicians in charge of the subjects of (5) (N=50)


Data will be collected through a web-based questionnaire survey.

Planned enrollment periods for each panel;
(1) Sep 1, 2023 to Dec 31, 2023
(2) Sep 1, 2023 to Dec 31, 2023
(3) Aug 14, 2023 to Oct 31, 2023
(4) Aug 14, 2023 to Jan 31, 2024
(5) Sep 1, 2023 to Nov 30, 2023
(6)Sep 1, 2023 to Jan 31, 2024

Registered date

2023

Year

08

Month

18

Day

Last modified on

2024

Year

02

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059261