Characterization of Placental Diffusion

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

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Diseases; Pregnancy in Diabetic
• Intervention / Treatment: Diagnostic test: DW-MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rinat Gabbay-Benziv, Prof; Phone Number: +972-4-7744514; Email: rinatg@hymc.gov.il
• Study Contact Backup: Name: Moran Rotman, MD; Phone Number: +972-4-7744514; Email: MORANR@hymc.gov.il

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Recruiting
    • Hille Yaffe Medical Center
    • Contact: Osnat Palgi Mirochnik, Bsc, RN; Phone Number: +974-47744602; Email: osnatp@hymc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women with gestational diabetes mellitus; 3Th trimester pregnant women with gestational diabetes mellitus	Diagnostic test: DW-MRI; Predict changes in ovarian diffusion using DW-MRI scan
Active Comparator: Low risk pregnant women; 3Th trimester pregnant women with unknown diseases (low risk factors)	Diagnostic test: DW-MRI; Predict changes in ovarian diffusion using DW-MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Two years

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Rinat Gabbay-Benziv, Prof, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Placenta Diseases; Pregnancy in Diabetics; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging
• Other Study ID Numbers: 0042-22-HYMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No