UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051403 |
|---|---|
| Receipt number | R000058506 |
| Scientific Title | Effect of Maternal Steroid and Antimicrobial Administration on Amniotic Fluid IL-6 Levels |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2023/12/20 10:39:33 |
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Basic information
Public title
Observational study on reduction of intra-amniotic inflammation by antimicrobial treatment in cases of preterm premature rupture of membranes with intra-amniotic infection.
Acronym
Observational Study of Intra-amniotic Infection and Antimicrobial treatment
Scientific Title
Effect of Maternal Steroid and Antimicrobial Administration on Amniotic Fluid IL-6 Levels
Scientific Title:Acronym
Effect of antimicrobial treatment on amniotic fluid IL-6 levels
Region
| Japan |
Condition
Condition
Intra-amniotic infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether intravenous administration of SBT/ABPC and AZM reduces interleukin 6 (IL-6) in the amniotic fluid of PPROM patients with intra-amniotic infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change and rate of change in amniotic fluid IL-6 levels between the initial and follow-up amniocentesis
Key secondary outcomes
The changes in the load of Ureaplasma spp. DNA in the amniotic fluid between the initial and follow-up amniocentesis
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
Singleton pregnancy patients who developed PPROM between 22 gestational weeks and 0 days and 33 gestational weeks 6 days (from August 2014 to April 2020).
Key exclusion criteria
Patients with an unclear time of membrane rupture, patients who underwent amniocentesis after amnioinfusion, patients who underwent amniocentesis more than 24 h after being diagnosed with PPROM, patients with unclear results of amniotic fluid culture, patients diagnosed with IAI alone or MIAC alone, patients who delivered <7 days after being diagnosed with PPROM, patients who were not administered previously arranged antibiotics, patients who did not undergo follow-up amniocentesis for any reason, and patients without either IAI or MIAC who had the secondary intra-amniotic infection before follow-up amniocentesis.
Target sample size
103
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomiyama |
Organization
National Hospital Organization, Saga National Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
849-8577
Address
Hinode 1-20-1, Saga, Japan
TEL
0952307141
nomiyama8522@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Nomiyama |
Organization
National Hospital Organization, Saga National Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
849-8577
Address
Hinode 1-20-1, Saga, Japan
TEL
0952307141
Homepage URL
nomiyama8522@gmail.com
Sponsor or person
Institute
National Hospital Organization, Saga National Hospital
Institute
Department
Personal name
Makoto Nomiyama
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of the National Hospital Organization Saga Hospital
Address
Hinode 1-20-1, Saga, Japan
Tel
0952307141
nomiyama8522@gmail.com
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
国立病院機構佐賀病院（佐賀県）/ National Hospital Organization, Saga National Hospital(Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 28 | 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
103
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
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Necessary data were extracted from the medical records.
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058506
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/23 | 後ろ向き研究計画書 (池田先生) (1).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/23 | Research Case Data Specifications 0623.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/23 | PROM-AZM dataset 0623 anonymized.xlsx |
