UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059334 |
|---|---|
| Receipt number | R000067850 |
| Scientific Title | A Prospective Longitudinal Observational Study on the Association Between Extracellular Vesicle Dynamics Derived from Central Nervous System Cells in Maternal and Umbilical Cord Blood from Pregnancy to the Postpartum Period and Postpartum Depression and Infant Developmental Outcomes |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 13:16:24 |
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Basic information
Public title
The Association Between Extracellular Vesicles Derived from Central Nervous System Cells and Postpartum Depression
Acronym
NEGEV-PPD (NEuron and Glia derived Extracellar Vesicles - PostPartum Depression)
Scientific Title
A Prospective Longitudinal Observational Study on the Association Between Extracellular Vesicle Dynamics Derived from Central Nervous System Cells in Maternal and Umbilical Cord Blood from Pregnancy to the Postpartum Period and Postpartum Depression and Infant Developmental Outcomes
Scientific Title:Acronym
NEGEV-PPD/ID (NEuron and Glia derived Extracellar Vesicles - PostPartum Depression and Infant Developmental Outcomes)
Region
| Japan |
Condition
Condition
normal pregnant
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the changes in the concentration of EVs derived from central nervous system cells (brain nerves and Greer) in maternal blood from early pregnancy to the postpartum period, and verify their predictive ability for postpartum depression.
Verify the relationship between the concentration of EVs derived from central nervous system cells (brain nerves and Greer) in umbilical cord blood and developmental indicators at six months after birth (Japanese version of ASQ-3).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between Edinburgh Postnatal Depression Scale (EPDS) total scores (continuous variables) at mid-pregnancy and one month postpartum, and concentrations of central nervous system-derived exogenous vascular (EV) components in the late pregnancy period (pre-delivery blood sampling)
Key secondary outcomes
Association between infant development at six months of age (Ages & Stages Questionnaires, Third Edition: ASQ-3 total and domain scores) and umbilical cord blood EV concentration.
Longitudinal changes in maternal EV concentration from early pregnancy to the postpartum period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women aged 18 or older who are scheduled to deliver at our hospital and can attend follow-up appointments until one month postpartum
Key exclusion criteria
Cases where informed consent cannot be obtained through Japanese-language explanation.
Multiple pregnancy.
Cases where severe fetal malformations or chromosomal abnormalities were confirmed before birth.
Intrauterine fetal death.
severe maternal complications.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tsubouchi |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
701-0114
Address
Matsushima 577, Kurashiki-shi, Okayama-ken, Japan
TEL
086-462-1111
h-tsubouchi@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tsubouchi |
Organization
Kawasaki Medical School
Division name
Obstetrics and Gynecology
Zip code
701-0114
Address
Matsushima 577, Kurashiki-shi, Okayama-ken, Japan
TEL
086-462-1111
Homepage URL
gyne@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School and Hospital Ethics Cmmittee
Address
Matsushima 577, Kurashikishi-shi, Okayama-ken, Japan
Tel
080-464-1076
kmsrec@med.kawasaki-m.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 | 10 | Month | 08 | 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
| 2024 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We Obtain informed consent for study participation at the initial visit. Maternal blood samples are collected at 10 weeks of gestation (T1), 26 weeks (T2), 37 weeks (T3), at delivery (T4), three days postpartum (P1), and one month postpartum (P2). Umbilical cord blood is collected at T4. Collected blood samples are promptly centrifuged, and the supenatant (EDTA plasma) is aliquoted and stored frozen. A fixed number of samples were pooled and shipped to NanoSomiX, Inc. (California, USA), where extracellular vesicle (EV) particle concentration was calculated using a sandwich immunoassay. Duplicate measurements were also performed at our institution using the same principle and standard series. Agreement was calculated after blinding to evaluate systematic error and reproducibility. The EV surface markers measured are, at most, ATP1A3(brain neuron marker), CD171(brain neuron marker), EAAT1 (astrocyte marker), MOG (oligodendrocyte marker), TMEM119(microglia marker), OXYTOCIN, PLAP(placenta-derived marker), CNTN2(fetal brain neuron marker), CD9(pan-EV marker). Participants will complete the Edinburgh Postnatal Depression Scale(EPDS) at T2 and P2, and the ASQ-3 at six months postpartum. The relationship between the transition of neuron and Greer derived EVs and each score will be statistically analyzed.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067850
