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Characterization of Placental Diffusion

Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06992245
Enrollment
40
Registered
2025-05-28
Start date
2023-07-06
Completion date
2027-12-31
Last updated
2025-12-24

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

Conditions

Pregnancy in Diabetic, Placenta Diseases

Brief summary

DW-MRI Allows a quantitative comparison of diffusion as an expression of tissue hypoxia. The investigators aim is to compare changes in placental diffusion in pregnant women with uncontrolled diabetes compared to healthy pregnant women using DW-MRI. The investigators hypothesize that placentas of diabetic mothers will show lower diffusion / perfusion compared to placentas of healthy women.

Detailed description

In highly uncontrolled diabetes there is an increased risk of intrauterine fetal death. The mechanism of fetal death is unknown and unpredictable. One of the theories points to hypoxia as a precursor to the death of the fetus in the womb. If the researchers succeed in predicting changes in the placenta with the help of MRI, it may be possible to understand the mechanism of fetal damage as well as in the future to develop a protocol for predicting pregnancies prone to fetal death in the womb.

Interventions

DIAGNOSTIC_TESTDW-MRI

Predict changes in ovarian diffusion using DW-MRI scan

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The 2 arms will include 3th trimester pregnant women. Group 1- diabetic pregnant women Group 2- low risk pregnant women

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Women with PGAM (Pre-gestational diabetes) diagnosed before 20 weeks of pregnancy * Women with GDMA (Gestational diabetes) diagnosed by OGTT after 20 weeks of pregnancy

Exclusion criteria

* pregnant women with placental hypoxia disease related in the past * pregnant women with placental hypoxia disease related in the present * non-singleton pregnancy * women in active labor or rupture of membrane * smoking women * suspicion of placenta accreta

Design outcomes

Primary

MeasureTime frameDescription
Placental diffusion coefficient (D) measured by IVIM-DWITwo yearsPlacental diffusion coefficient (D, mm²/s) derived from intravoxel incoherent motion diffusion-weighted MRI (IVIM-DWI). Mean D values will be extracted from whole-placenta regions of interest and compared between parturients with poorly controlled diabetes and excessive fetal growth and low-risk parturients with appropriately grown fetuses.

Secondary

MeasureTime frameDescription
Placental perfusion fraction (f) measured by IVIM-DWITwo yearsPlacental perfusion fraction (f, unitless) derived from intravoxel incoherent motion diffusion-weighted MRI (IVIM-DWI). Mean f values will be extracted from whole-placenta regions of interest and compared between parturients with poorly controlled diabetes and excessive fetal growth and low-risk parturients with appropriately grown fetuses

Countries

Israel

Contacts

Primary ContactRinat Gabbay-Benziv, Prof
rinatg@hymc.gov.il+972-4-7744514
Backup ContactMoran Rotman, MD
MORANR@hymc.gov.il+972-4-7744514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026