Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059334) titled 'The Association Between Extracellular Vesicles Derived from Central Nervous System Cells and Postpartum Depression' on Oct. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Kawasaki Medical School
Condition:
Condition - normal pregnant
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 10 Month 06 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067850
Disclaimer: Curated by HT Syndication.
