The Association Between Extracellular Vesicles Derived from Central Nervous System Cells and Postpartum Depression

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 - NEGEV-PPD/ID (NEuron and Glia derived Extracellar Vesicles - PostPartum Depression and Infant Developmental Outcomes)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059334

Enrollment

300

Registered

2025-10-08

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

normal pregnant

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactHiroaki Tsubouchi

Kawasaki Medical School Obstetrics and Gynecology

gyne@med.kawasaki-m.ac.jp086-462-1111

Outcome results