UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062533 |
|---|---|
| Receipt number | R000070910 |
| Scientific Title | A Retrospective Cohort Study on the Pregnancy Course and Delivery Outcomes of Threatened Preterm Labor, Comprising Preterm Labor and Other High-Risk Statuses |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/02 09:21:30 |
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Basic information
Public title
A Retrospective Cohort Study on the Pregnancy Course and Delivery Outcomes of Threatened Preterm Labor, Comprising Preterm Labor and Other High-Risk Statuses
Acronym
Outcomes of Preterm Labor and Other High-Risk Statuses: A Cohort Study
Scientific Title
A Retrospective Cohort Study on the Pregnancy Course and Delivery Outcomes of Threatened Preterm Labor, Comprising Preterm Labor and Other High-Risk Statuses
Scientific Title:Acronym
Outcomes of Preterm Labor and Other High-Risk Statuses: A Cohort Study
Region
| Japan |
Condition
Condition
Preterm Labor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in the clinical course between preterm labor and threatened preterm labor, and to demonstrate the importance of strictly distinguishing between the two
Basic objectives2
Others
Basic objectives -Others
Description of clinical course and epidemiological analysis.Subsequently, as part of the secondary analysis, stratified analysis, etc.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number and rate of spontaneous preterm birth
Key secondary outcomes
Risk factors for preterm birth, symptoms and underlying factors that may lead to preterm labor, etc.
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
Pregnant women admitted for management due to "threatened preterm labor" before 34 weeks of gestation
Key exclusion criteria
Uterine malformation, multiple pregnancy, history of prior cesarean delivery, history of prior myomectomy, fetal malformation, preterm premature rupture of membrane prior to onset of threatened preterm labor, abnormal placental location, refusal to participate in the study, determination to be inappropriate by the researcher.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Honda |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Obstetrics and Gynecology
Zip code
1838524
Address
Musashidai 2-8-29 Fuchu-shi,Tokyo
TEL
0423235111
izumi_honda@tmhp.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Honda |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Obstetrics and Gynecology
Zip code
1838524
Address
Musashidai 2-8-29 Fuchu-shi, Tokyo
TEL
0423235111
Homepage URL
izumi_honda@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Organization of Prevention of Preterm Delivery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
research Ethics Committee, Tokyo Metropolitan Hospital Organization
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, 183-8561, Japan
Tel
0423005111
tmerp_erb@tmhp.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
天使病院(北海道)
弘前大学医学部附属病院(青森県)
岩手県立中央病院(岩手県)
岩手医科大学附属病院(岩手県)
岩手県立大船渡病院(岩手県)
東邦大学医療センター大森病院(東京都)
東京都立大塚病院(東京都)
東京都立多摩総合医療センター(東京都)
東京科学大学病院(東京都)
愛育病院(東京都)
杏林大学医学部付属病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
日本医科大学多摩永山病院(東京都)
昭和医科大学江東豊洲病院(東京都)
東京都立墨東病院(東京都)
帝京大学医学部附属病院(東京都)
国立成育医療研究センター(東京都)
日本赤十字社医療センター(東京都)
日本医科大学付属病院(東京都)
埼玉医科大学病院(埼玉県)
埼玉病院(埼玉県)
さいたま赤十字病院(埼玉県)
国際医療福祉大学成田病院(千葉県)
順天堂大学医学部附属浦安病院(千葉県)
山口病院(千葉県)
新潟大学医歯学総合病院(新潟県)
長野県立こども病院(長野県)
静岡済生会総合病院(静岡県)
名古屋市立大学病院(愛知県)
名古屋大学医学部附属病院(愛知県)
京都府立医科大学附属病院(京都府)
大阪母子医療センター(大阪府)
医学研究所北野病院(大阪府)
大阪市立総合医療センター(大阪府)
岡山医療センター(岡山県)
倉敷中央病院(岡山県)
広島市立広島市民病院(広島県)
広島大学病院(広島県)
岩国医療センター(山口県)
高知大学医学部附属病院(高知県)
福岡大学病院(福岡県)
佐賀病院(佐賀県)
佐世保市総合医療センター(長崎県)
長崎医療センター(長崎県)
大分大学医学部附属病院(大分県)
鹿児島市立病院(鹿児島県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 10 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Maternal age, height and weight, medical history, comorbidities, clinical findings during pregnancy, and interventions performed, etc.
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070910
