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RecruitingNCT06992245Updated Dec 24, 2025

Characterization of Placental Diffusion

An interventional study of DW-MRI in Pregnancy in Diabetic and Placenta Diseases, sponsored by Hillel Yaffe Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy in Diabetic
  • Placenta Diseases
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Pregnant women with gestational diabetes mellitus

    3Th trimester pregnant women with gestational diabetes mellitus

    Diagnostic Test: DW-MRI

  • Active comparator
    Low risk pregnant women

    3Th trimester pregnant women with unknown diseases (low risk factors)

    Diagnostic Test: DW-MRI

Interventions

  • Diagnostic testDW-MRI

    Predict changes in ovarian diffusion using DW-MRI scan

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

06

Study locations

1 of 1 sites recruiting
  • Hille Yaffe Medical Center
    Hadera, 38100, Israel
    Recruiting
07

Registry details

Key details

Study ID
NCT06992245
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
May 28, 2025
Start date
Jul 6, 2023
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Dec 24, 2025

Study contacts

Rinat Gabbay-Benziv, Prof
Contact
rinatg@hymc.gov.il
+972-4-7744514
Moran Rotman, MD
Contact
MORANR@hymc.gov.il
+972-4-7744514
Rinat Gabbay-Benziv, Prof
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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