UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059353 |
|---|---|
| Receipt number | R000067885 |
| Scientific Title | Efficacy of Expectant Management for Preterm Subclinical Intra-Amniotic Infection |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/02/27 13:34:37 |
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Basic information
Public title
Efficacy of Expectant Management for Preterm Subclinical Intra-Amniotic Infection
Acronym
Expectant Management for Intra-Amniotic Infection
Scientific Title
Efficacy of Expectant Management for Preterm Subclinical Intra-Amniotic Infection
Scientific Title:Acronym
Expectant Management for Intra-Amniotic Infection
Region
| Japan |
Condition
Condition
Preterm Subclinical Intra-Amniotic Infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study assessed the efficacy of expectant management in patients with intra-amniotic infections diagnosed treated at our institution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the proportion of patients in which the interval from the diagnosis of infection to delivery exceeded 48 h without exacerbation of IAI, as compared between the U/Mh-only and other bacteria groups.
Key secondary outcomes
Secondary outcome was assessed at the same interval, but extended to 168 h.
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) singleton gestation between 20+0 and 33+6 weeks; (2) transabdominal amniocentesis performed to assess microbiological and inflammatory status of the amniotic cavity; (3) diagnosis of intra-amniotic infection; and (4) expectant management.
Key exclusion criteria
(1) decision to terminate pregnancy after a diagnosis of intra-amniotic infection; (2) antimicrobial administration within seven days prior to amniocentesis; (3) secondary intra-amniotic infection; (4) fetal congenital structural or chromosomal abnormalities; and (5) induction of labor within 48 h of infection diagnosis due to oligohydramnios or infection itself.
Target sample size
42
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
Funding Source
Organization
NHO Saga Hospital
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
NHO 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
佐賀県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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/41725271
Number of participants that the trial has enrolled
42
Results
Of 56 diagnosed patients, 42 were analyzed. Pregnancy was prolonged beyond 48 h without exacerbation in 71.9% of the women in a U/Mh-only group compared with 30.0% in the other bacterial group (P=0.03). However, pregnancy was not significantly prolonged beyond 168 h in the U/Mh-only group compared with that in the other bacterial group (28.1% vs. 0%, P=0.09).
Results date posted
| 2025 | Year | 10 | Month | 09 | Day |
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
| 2025 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
Primary outcome was the proportion of patients in which the interval from the diagnosis of infection to delivery exceeded 48 h without exacerbation of IAI, as compared between the U/Mh-only and other bacteria groups. Exacerbation of IAI was defined as an amniotic fluid IL-6 concentration exceeding the pre-treatment level at 48+-12 h after diagnosis or 36 h before. If no amniocentesis was performed within 48+-12 h after diagnosis, the values before and after this interval were connected by a straight line, and the intersection with 48 h was used as the post-treatment value.
Secondary outcome was assessed at the same interval, but extended to 168 h. Exacerbation of IAI was defined as an amniotic fluid IL-6 concentration exceeding the pre-treatment level at 168+-17 h after diagnosis or before 151 h. If no amniocentesis was performed within 168+-17 h after diagnosis, the values before and after this interval were connected by a straight line, and the intersection with 168 h was used as the post-treatment value.
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067885
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/10/09 | 子宮内感染に対する保存的治療研究計画書 20250116.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/10/09 | データ仕様.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/10/09 | データ仕様.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/67885
