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Intrauterine Exosomes therapy (IUET) in the setting of severe early onset Fetal Growth Restriction (FGR)

Intrauterine Exosomes therapy (IUET) in the setting of severe early onset Fetal Growth Restriction (FGR) (Clinical trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140317017034N10
Enrollment
20
Registered
2024-10-22
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Fetal Growth Restriction. Disorders of newborn related to slow fetal growth and fetal malnutrition

Interventions

Intervention 1: Intervention group: In the case group Intrauterine exosomes transfusion [100 µ per fetal weight (Kg) in 2 dosages apart one week] was done via umbilical vein like a routine method for

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Stage II, III of early-onset FGR between 24-32 WKS

Exclusion criteria

Exclusion criteria: Major anatomical abnormalities during anomaly scan Genetic disorders in amniocentesis report Fetal infection-Maternal comorbid disease Premature rupture of membrane, active preterm labor Maternal active viral disease Multiple pregnancy vaginal bleeding Gestational age below 24 wks

Design outcomes

Primary

MeasureTime frame
Biometry fetal(fetal weight, Utero-fetal-placental Dopplers, amniotic fluid index). Timepoint: weekly. Method of measurement: Sonography.;NICU admission. Timepoint: After birth. Method of measurement: clinical.;Neurological development. Timepoint: at 6-month-old. Method of measurement: ASQ form.;Placental growth factor (PLGF). Timepoint: before and after treatment. Method of measurement: Kit.;Microscopic and macroscopic placental pathology. Timepoint: After delivery. Method of measurement: Clinical and laboratory (microscope).;Apgar score. Timepoint: After birth. Method of measurement: Clinical.;Soluble fms-like tyrosine kinase receptor-1 (sFlt-1) factor. Timepoint: before and after treatment. Method of measurement: Eliza kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShohreh Roozmeh

Shiraz University of Medical Sciences

dr.roozmeh1995@yahoo.com+98 71 3612 8258

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026