UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037278 |
|---|---|
| Receipt number | R000042363 |
| Scientific Title | An attempt to classify Gram-stained vaginal smears with a Nugent score of 4 into four bacterial morphotypes at first prenatal visit |
| Date of disclosure of the study information | 2019/07/08 |
| Last modified on | 2019/07/05 12:31:21 |
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Basic information
Public title
An attempt to classify Gram-stained vaginal smears with a Nugent score of 4 into four bacterial morphotypes at first prenatal visit
Acronym
An attempt to classify Gram-stained vaginal smears with a Nugent score of 4 into four bacterial morphotypes at first prenatal visit
Scientific Title
An attempt to classify Gram-stained vaginal smears with a Nugent score of 4 into four bacterial morphotypes at first prenatal visit
Scientific Title:Acronym
An attempt to classify Gram-stained vaginal smears with a Nugent score of 4 into four bacterial morphotypes at first prenatal visit
Region
| Japan |
Condition
Condition
Nugent score 4 of Gram stained vaginal smear at the first prenatal visit.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to study the bacterial morphotype, except for the mixed-type of Lactobacillus and Gardnerella or Bacteroides spp. In the Nugent Score4 group. The resulting Nugent Score 4 organisms except for mixed-type were further classified into the following three types: Gram positive cocci type, Bifidobacterium type, and non-bacterial type. The clinical courses for all the types except mixed-type were followed- up and evaluate the benefit of four type of bacterial classification of Nugent score 4.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the pregnancy outcome of the three vaginal flora types
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
No intervention for Bifidobacterium type
Interventions/Control_2
Treatment with penicillin (2g/day for 5 days) and tocolytics until 37 weeks of gestation for Gram positive cocci type
Interventions/Control_3
Treatment prophylactic antibiotics for 5 days for non-bacterial type
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
| 16 | years-old | <= |
Age-upper limit
| 43 | years-old | >= |
Gender
Female
Key inclusion criteria
Nugent score 4 with Gram stained vaginal smear
Key exclusion criteria
Mixed type with Nugent score 4 with vaginal smear
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Shimano |
Organization
Nakashibetsu Munispal Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
086-1110
Address
W 10-jo, S9-chome, Nakashibetsu-Cho, Hokkaido
TEL
81153728200
shima722@beach.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shimano |
Organization
Nakashibetsu Munispal Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
086-1110
Address
W 10-jo, S9-chome, Nakashibetsu-Cho, Hokkaido
TEL
81153728200
Homepage URL
shima722@beach.ocn.ne.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology
Nakashibetsu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology
Kitami Red Cross Hospital
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
Kitami Red Cross Hospital
Address
N 6-jo, E 2-Chome, Kitami city, Hokkaido, Japan
Tel
81157243115
m_mizunuma@kitami.jrc.or.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
| 2019 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
We read a paper on a suject at 23th congress of Japanese Society for Clinical Microbiology(Yokohama city).We may guess the mixed bacterial type from the diagnosis of Nugent score 4, however, there are Biffidobacterium spp only type, gram positive coccie type and no bacteria type was exactly existed. The record of these three vaginal bacterial type are need because the therapy is different according to the various bacterial type.
Results date posted
| 2019 | Year | 07 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The submitting paper is under consideration.
Date of the first journal publication of results
| 2012 | Year | 01 | Month | 22 | Day |
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
| 2009 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042363
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/14 | AMI_shimano.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
