UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047596 |
|---|---|
| Receipt number | R000053848 |
| Scientific Title | Feasibility study of high-risk pregnancy management with home monitoring using the small mobile cardiotocography |
| Date of disclosure of the study information | 2022/04/26 |
| Last modified on | 2025/04/30 17:18:41 |
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Basic information
Public title
Feasibility study of high-risk pregnancy management with home monitoring using the small mobile cardiotocography
Acronym
Feasibility study of high-risk pregnancy management with home monitoring using the small mobile cardiotocography
Scientific Title
Feasibility study of high-risk pregnancy management with home monitoring using the small mobile cardiotocography
Scientific Title:Acronym
Feasibility study of high-risk pregnancy management with home monitoring using the small mobile cardiotocography
Region
| Japan |
Condition
Condition
Threatened preterm labor
Fetal growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of high-risk pregnancy management with home monitoring using the small mobile cardiotocography in cases of threatened preterm labor and fetal growth restriction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of cases in which the obstetrician responded to abnormalities in the acquired cardiotocography data
Key secondary outcomes
Analysis of cases judged to require hospitalization by the obstetrician according to the acquired data.
Analysis of the acquired cardiotocography data.
Satisfaction survey of the subjects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using of the small mobile cardiotocography at home
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.
Cases of fetal growth restriction after 28 weeks of gestation
2.
Cases of threatened premature labor after 28 weeks of gestatio
Key exclusion criteria
Cases of placenta previa and low-lying placenta
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kamei |
Organization
Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
350-0495
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama, Japan
TEL
0492761347
ykamei@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | SHUNSUKE |
| Middle name | |
| Last name | Tamaru |
Organization
Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
350-0495
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama, Japan
TEL
0492761347
Homepage URL
stamaru@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Obstetrics and Gynecology Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama, Japan
Tel
0492761354
hirb@saitama-med.ac.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
埼玉医科大学病院（埼玉県）、自治医科大学附属さいたま医療センター（埼玉県）、聖マリアンナ医科大学病院（神奈川県）、東京医科大学病院（東京都）、東京慈恵会医科大学附属病院（東京都）、東京大学医学部附属病院（東京都）、日本医科大学付属病院（東京都）、宮崎大学医学部附属病院（宮崎県）、日本大学附属板橋病院（東京都）、熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
61
Results
Sixty-three cases (30 of threatened preterm delivery, 34 of fetal growth restriction, and 3 overlapping cases) were included in the study.Emergency hospitalizations during the study period occurred in 19 of 61 cases (31.4%), of which 1 case (4.7%) was indicated for hospitalization based on the findings of the home monitor. In one other case, an order to come to the hospital was made based on the findings of the home monitor.
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was conducted at 10 university hospitals using a small mobile CTG (iCTG) from Melody International. Single-pregnant women after 28 weeks with a diagnosis of either threatened preterm labor (cervical canal length <25 mm or with genital bleeding) or fetal growth restriction (estimated infant weight -1.5 SD or less) were included in the study.
Participant flow
The iCTG was lent to the subject and the subject was instructed to wear it at least once a week for at least 40 minutes. Data were monitored in real time by the doctor in charge, and the subject was contacted by phone when medical attention was necessary. Subjects were surveyed with a questionnaire at the end of the study.
Adverse events
None
Outcome measures
Emergency hospitalization
Cases of phone calls
Serious complications
Questionnaire results
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053848
