UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057586 |
|---|---|
| Receipt number | R000065801 |
| Scientific Title | Development and Validation of a Predictive Model for Fetal Circulatory Assessment Based on the Relationship Between Fetal Ultrasound Findings and Umbilical Cord NT-proBNP in Pregnancies With Placental or Umbilical Cord Abnormalities |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/10/14 09:46:01 |
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Basic information
Public title
Development and Validation of a Predictive Model for Fetal Circulatory Assessment Based on the Relationship Between Fetal Ultrasound Findings and Umbilical Cord NT-proBNP in Pregnancies With Placental or Umbilical Cord Abnormalities
Acronym
Development and Validation of a Predictive Model for Umbilical Cord NT-proBNP Using Fetal Ultrasound
Scientific Title
Development and Validation of a Predictive Model for Fetal Circulatory Assessment Based on the Relationship Between Fetal Ultrasound Findings and Umbilical Cord NT-proBNP in Pregnancies With Placental or Umbilical Cord Abnormalities
Scientific Title:Acronym
Development and Validation of a Predictive Model for Umbilical Cord NT-proBNP Using Fetal Ultrasound
Region
| Japan |
Condition
Condition
Pregnant women with placental or umbilical cord abnormalities
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a predictive model for umbilical cord NT-proBNP levels based on fetal ultrasound findings, in order to non-invasively assess fetal circulatory status in pregnancies at risk of neonatal circulatory failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Umbilical cord NT-proBNP concentration
Key secondary outcomes
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
Participants must meet all of the following criteria:
1.Singleton pregnancy
2.Presence of at least one of the following conditions:
a. Fetal growth restriction (FGR)
b. Hypertensive disorders of pregnancy (including chronic hypertension)
c. Velamentous cord insertion
d. Abnormal cord insertion (e.g., marginal insertion, membranous insertion, tent-shaped, fork-shaped insertion)
e. Other placental or umbilical cord abnormalities deemed to pose a risk of fetal cardiac overload by the attending physician
3.Delivery at or after 22 weeks of gestation
4.Written informed consent obtained from the participant
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria:
1.Unknown or unreliable gestational age
2.Stillbirth
3.Any case judged by the principal investigator to be inappropriate for inclusion
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Tadakawa |
Organization
Tohoku University Hospital
Division name
Obstetrics and Gynecology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
mari.tadakawa.c2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | SHOKO |
| Middle name | |
| Last name | SAITO |
Organization
Tohoku University Hospital
Division name
Obstetrics and Gynecology
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
Homepage URL
shoko_saito.y8k8@tohoku.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Ethics Committee of the Graduate School of Medicine, Tohoku University
Address
2-1, Seiryo-machi, Aoba-ku, Se dai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary outcome of this study is the umbilical cord NT-proBNP concentration collected immediately after birth. Based on fetal ultrasound findings obtained during pregnancy, a predictive model will be constructed. If a non-invasive and repeatable method for evaluating fetal circulatory dynamics can be established, it may aid in clinical decision-making regarding the optimal timing and mode of delivery.
Management information
Registered date
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065801
