UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060005 |
|---|---|
| Receipt number | R000068629 |
| Scientific Title | Antimicrobial Susceptibility Profiles of Amniotic Fluid Microorganisms: Limited Ampicillin Coverage and Clinical Implications for the Management of Intra-amniotic Infection |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/08/29 09:49:19 |
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Basic information
Public title
Antimicrobial Susceptibility Profiles of Amniotic Fluid Microorganisms: Limited Ampicillin Coverage and Clinical Implications for the Management of Intra-amniotic Infection
Acronym
Antimicrobial Susceptibility Profiles of Amniotic Fluid Microorganisms: Limited Ampicillin Coverage and Clinical Implications for the Management of Intra-amniotic Infection
Scientific Title
Antimicrobial Susceptibility Profiles of Amniotic Fluid Microorganisms: Limited Ampicillin Coverage and Clinical Implications for the Management of Intra-amniotic Infection
Scientific Title:Acronym
Antimicrobial Susceptibility Profiles of Amniotic Fluid Microorganisms: Limited Ampicillin Coverage and Clinical Implications for the Management of Intra-amniotic Infection
Region
| Japan |
Condition
Condition
Intra-amniotic infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ampicillin (ABPC) susceptibility of microorganisms isolated from amniotic fluid and to assess antimicrobial susceptibility patterns, including new organisms emergence after antibiotics initiation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the proportion of pregnancies in which all cultured microorganisms were susceptible to ABPC. Cases were classified as ABPC-susceptible only when every isolate demonstrated susceptibility.
Key secondary outcomes
The secondary outcomes were:
(1) the susceptibility of ABPC-non-susceptible organisms (excluding Ureaplasma spp., M. hominis, and fungi) to other antibiotics;
(2) the interval from the initiation of antibiotic therapy to the detection of newly emerging organisms and their susceptibility to the administered agents; and
(3) the ABPC and GM susceptibility of microorganisms that were detected in the amniotic fluid of neonates who developed EONS.
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
We reviewed singleton pregnancies that underwent amniocentesis for suspected intra-amniotic infection between August 2014 and October 2023.
Key exclusion criteria
The exclusion criteria included mechanical cervical dilation, induced labor or artificial rupture of membranes before sampling, intrauterine fetal demise, major fetal structural anomalies, and insufficient clinical data.
Target sample size
678
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomiyama |
Organization
NHO Saga 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
NHO Saga 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
NHO Saga Hospital
Institute
Department
Personal name
Makoto Nomiyama
Funding Source
Organization
NHO Saga Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Saga Hospital the institutional review board
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
佐賀県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/42287867
Number of participants that the trial has enrolled
631
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
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Maternal clinical characteristics (age, sex, height, weight, medical history, and amniotic fluid findings) 2. Neonatal clinical characteristics (sex, birth length, birth weight, and medical history)
Management information
Registered date
| 2025 | Year | 12 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068629
| Research Plan | |
|---|---|
| Registered date | File name |
| 2026/03/27 | TwinSingleMIR.xlsx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/12/07 | 仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2026/03/27 | TwinSingleMIR.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/68629
