UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040126 |
|---|---|
| Receipt number | R000045536 |
| Scientific Title | Clinical effectiveness of Ji-daboku-Ippo in the obstetrics and gynecology department : A propensity score-matched study |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2023/10/28 08:38:53 |
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Basic information
Public title
Clinical effectiveness of Ji-daboku-Ippo in the obstetrics and gynecology department : A propensity score-matched study
Acronym
Clinical effectiveness of Ji-daboku-Ippo in the obstetrics and gynecology department
Scientific Title
Clinical effectiveness of Ji-daboku-Ippo in the obstetrics and gynecology department : A propensity score-matched study
Scientific Title:Acronym
Clinical effectiveness of Ji-daboku-Ippo in the obstetrics and gynecology department
Region
| Japan |
Condition
Condition
Perineal pain after delivery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of Ji-daboku-Ippo (JDI) for patients with perineal pain after delivery, we are going to study using propensity score matching.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpartum perineal pain
Key secondary outcomes
Postpartum activities of daily living
Perineal hematoma or swelling after delivery
Prescribed amount of non-steroidal anti-inflammatory drugs (NSAIDs)
C-reactive protein level on the second day postpartum
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
| 12 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who performed vaginal births at the Obstetrics and Gynecology of Higashiosaka Medical Center between June 2014 and May 2018
Key exclusion criteria
Exclusion criteria as following
(1) Patients with little or no prenatal care
(2) Patients who lack pre-pregnancy imformation
(3) Patients judged inappropriate by the person in charge of this study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Hagihara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Advanced Hybrid Medicine
Zip code
565-0781
Address
2-2 Yamadaoka Suita-City Osaka
TEL
06-6210-8349
k.hagihara@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Saito |
Organization
Higashiosaka City Medical Center
Division name
Obsterics and gynecology
Zip code
578-8588
Address
3-4-5 Nishiiwata Higashiosaka-City Osaka
TEL
06-6781-5101
Homepage URL
https://www.higashiosaka-mc.jp
hitomis.og@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Higashiosaka City Medical Center
Address
3-4-5 Nishiiwata Higashiosaka-City Osaka
Tel
06-6781-5101
hcmc-chiken@higashiosaka-hosp.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 | 04 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 30 | Day |
Other
Other related information
This study is designed as a retrospective study. We are going to investigate the effectiveness of JDI on perineal pain compared to control group based on the propensity score matching.
The factors will be used for matching are as follows,vacuum extraction, Kristeller maneuver, episiotomy, the degree of perineal laceration, perineal hematoma or swelling after delivery, and first birth.
Management information
Registered date
| 2020 | Year | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045536
