UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048927 |
|---|---|
| Receipt number | R000055562 |
| Scientific Title | Enhanced Recovery After Cesarean and Obstetric Quality of Recovery Score: A Prospective Before-After Comparison Study |
| Date of disclosure of the study information | 2022/09/13 |
| Last modified on | 2023/08/10 15:25:42 |
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Basic information
Public title
Enhanced Recovery After Cesarean and Obstetric Quality of Recovery Score: A Prospective Before-After Comparison Study
Acronym
ERAC & ObsQoR
Scientific Title
Enhanced Recovery After Cesarean and Obstetric Quality of Recovery Score: A Prospective Before-After Comparison Study
Scientific Title:Acronym
ERAC & ObsQoR
Region
| Japan |
Condition
Condition
Cesarean delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implementing an enhanced analgesia strategy after cesarean delivery would improve patient recovery measured with the Obstetric Quality of Recovery score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Obstetric Quality of Recovery
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 elective Cesarean Delivery
- 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
- General anesthesia
- Intrapartum cesarean
- Known liver dysfunction
- Known renal dysfunction
Target sample size
50
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
Department of Obstetric Anesthesiology, Center for Maternal-Fetal and Neonatal Medicine
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3654
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
Department of Obstetric Anesthesiology, Center for Maternal-Fetal and Neonatal Medicine
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3654
Homepage URL
mazda@saitama-med.ac.jp
Sponsor or person
Institute
Department of Obstetric Anesthesiology, Center for Maternal-Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
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
smcrinri@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective before-and-after study
Management information
Registered date
| 2022 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
