UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054025 |
|---|---|
| Receipt number | R000061661 |
| Scientific Title | Implications of Mycoplasma and Ureaplasma infections on perinatal outcomes |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/03/31 14:36:17 |
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Basic information
Public title
Implications of Mycoplasma and Ureaplasma infections on pregnant women
Acronym
Implications of Mycoplasma and Ureaplasma infections on pregnant women
Scientific Title
Implications of Mycoplasma and Ureaplasma infections on perinatal outcomes
Scientific Title:Acronym
Implications of Mycoplasma and Ureaplasma infections on perinatal outcomes
Region
| Japan |
Condition
Condition
Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the prevalence of Mycoplasma, Ureaplasma infections
To consider whether to affect perinatal outcomes
Basic objectives2
Others
Basic objectives -Others
To analyze the prevalence of Mycoplasma, Ureaplasma infections
To consider whether to affect perinatal outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of Mycoplasma, Ureaplasma infections
Perinatal outcomes
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who are managed in our hospital from 1st trimester to delivery.
Key exclusion criteria
Pregnant women transferred from another hospital from 2nd trimester
Pregnant women interrupted maternal check-up due to transfer to another hospital
Pregnant women without any maternal check-up
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kiichiro,Masanori |
| Middle name | |
| Last name | Furuya,Sumi |
Organization
Rinku General Medical Center
Division name
Obstetrics and gynecology
Zip code
598-8577
Address
Rinku Ouraikita 2-23, Izumisanoshi, Osaka
TEL
072-469-3111
k-ogita@rgmc.izumisano.osaka.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Sumi |
Organization
Rinku General Medical Center
Division name
Obstetrics and gynecology
Zip code
598-8577
Address
Rinku Ouraikita 2-23, Izumisanoshi, Osaka
TEL
072-469-3111
Homepage URL
k-ogita@rgmc.izumisano.osaka.jp
Sponsor or person
Institute
Rinku General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Rinku General Medical Center
Address
Rinku Ouraikita 2-23, Izumisanoshi, Osaka
Tel
072-469-3111
rinri@rgmc.izumisano.osaka.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
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061661
