UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057879 |
|---|---|
| Receipt number | R000066155 |
| Scientific Title | A Prospective Observational Study on the Association Between Amniotic Fluid Biomarkers and Intrauterine Infection During Pregnancy |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/16 13:37:36 |
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Basic information
Public title
A Prospective Observational Study on the Association Between Amniotic Fluid Biomarkers and Intrauterine Infection During Pregnancy
Acronym
A Prospective Observational Study on the Association Between Amniotic Fluid Biomarkers and Intrauterine Infection During Pregnancy
Scientific Title
A Prospective Observational Study on the Association Between Amniotic Fluid Biomarkers and Intrauterine Infection During Pregnancy
Scientific Title:Acronym
A Prospective Observational Study on the Association Between Amniotic Fluid Biomarkers and Intrauterine Infection During Pregnancy
Region
| Japan |
Condition
Condition
Pregnant women with suspected intrauterine infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic utility of amniotic fluid biomarkers for intrauterine infection during pregnancy
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of histological chorioamnionitis
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
(1) Pregnant women receiving perinatal care at our institution
(2) Cases in which intrauterine infection is suspected during pregnancy and amniotic fluid is collected for clinical purposes
(3) Individuals who have provided written informed consent or are included based on opt-out procedures
Key exclusion criteria
(1) Cases in which amniotic fluid biomarker measurement was not performed
(2) Cases in which pathological examination of the placenta and umbilical cord was not conducted after delivery
(3) Cases in which a prolonged interval between amniotic fluid biomarker measurement and submission of placental pathological specimens is deemed analytically inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
masatoshi.saito.b4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | SHOKO |
| Middle name | |
| Last name | SAITO |
Organization
Tohoku University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
Homepage URL
shoko_saito.y8k8@tohoku.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogyaa Donation Foundation (Japan Association of Obstetricians and Gynecologists)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Graduate School of Medicine, Tohoku University
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Early diagnosis of chorioamnionitis during pregnancy may help reduce the risk of fetal inflammatory response syndrome (FIRS) and subsequent neonatal complications and long-term sequelae.
Management information
Registered date
| 2025 | Year | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066155
