Characterization of Placental Diffusion

Hillel Yaffe Medical Center40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pregnancy in Diabetic Placenta Diseases

Interventions

DW-MRIDIAGNOSTIC_TEST

Predict changes in ovarian diffusion using DW-MRI scan

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hille Yaffe Medical Center

Hadera, Israel

RECRUITING

Outcomes

Primary Outcomes

Placental diffusion coefficient (D) measured by IVIM-DWI

Placental 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.

Time frame: Two years

Secondary Outcomes

Placental perfusion fraction (f) measured by IVIM-DWI

Placental 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

Time frame: Two years

Central Contacts

Rinat Gabbay-Benziv, Prof

CONTACT

+972-4-7744514 rinatg@hymc.gov.il

Moran Rotman, MD

CONTACT

+972-4-7744514 MORANR@hymc.gov.il

Data from ClinicalTrials.gov

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