UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043032
Receipt number R000047432
Scientific Title Evaluation of a translated Japanese version of ObsQoR-10
Date of disclosure of the study information 2021/01/16
Last modified on 2022/08/26 14:53:21

* 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

Evaluation of a translated Japanese version of ObsQoR-10

Acronym

ObsQoR-10JP

Scientific Title

Evaluation of a translated Japanese version of ObsQoR-10

Scientific Title:Acronym

ObsQoR-10JP

Region

Japan


Condition

Condition

Cesarean & vaginal delivery

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Primary aim
Assess in-patient recovery following elective cesarean delivery and vaginal delivery using ObsQoR-10 (Japanese) and EQ5D (Japanese)

Basic objectives2

Others

Basic objectives -Others

Secondary aims
To psychometrically evaluate the ObsQoR-10 (Japanese) patient-reported outcome measure.

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ObsQoR-10 Japanese version (24 hours after delivery to Day 7)

Key secondary outcomes

EQ5D Japanese version (24 hours after delivery)
Global Health Status (24 hours after delivery)


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

18 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

- Japanese-speaking women greater than 18 years of age who have spontaneous vaginal delivery (including repair of vaginal tears and manual removal of placenta) or elective Cesarean Delivery
- Nulliparous ie first baby
- We will include all women who have singleton births
- Greater than 37 weeks gestational age

Key exclusion criteria

- Age < 18 years
- Women whose infants have died
- Mother or baby requiring ICU after delivery.
- Patient refusal
- Inability to read or understand written Japanese
- Failed neuraxial analgesia: elective cesarean delivery
- General anesthesia
- Intrapartum cesarean
- Assisted/operative (i.e. vacuum, forceps) vaginal delivery
- Previous live birth

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Mazda

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Obstetric Anesthesia, Department of Anesthesiology

Zip code

350-8550

Address

1981 Kamoda, Kawagoe, Saitama, Japan

TEL

049-228-3400

Email

mazda@saitama-med.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Mazda

Organization

Saitama Medical Center, Saitama Medical University

Division name

Division of Obstetric Anesthesia, Department of Anesthesiology

Zip code

350-8550

Address

1981 Kamoda, Kawagoe, Saitama, Japan

TEL

049-228-3400

Homepage URL


Email

mazda@saitama-med.ac.jp


Sponsor or person

Institute

Division of Obstetric Anesthesia, Department of Anesthesiology, Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Division of Obstetric Anesthesia, Department of Anesthesiology, Saitama Medical Center, Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Anesthesiology, Stanford University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB Saitama Medical Center

Address

1981 Kamoda, Kawagoe, Saitama, Japan

Tel

049-228-3400

Email

smcmir@saitama-med.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

埼玉医科大学総合医療センター(埼玉県)


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 16 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

Completed

Date of protocol fixation

2020 Year 09 Month 30 Day

Date of IRB

2020 Year 10 Month 01 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2022 Year 05 Month 24 Day

Date of closure to data entry

2022 Year 07 Month 19 Day

Date trial data considered complete

2022 Year 08 Month 01 Day

Date analysis concluded



Other

Other related information

ObsQoR10, EQ5D


Management information

Registered date

2021 Year 01 Month 16 Day

Last modified on

2022 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047432


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name