Characterization of Placental Diffusion

NCT06992245 | Recruiting DMC

• 1 other identifier: 0042-22-HYMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Diseases; Pregnancy in Diabetic

Outcome Measures

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.

  Two years

Secondary Outcomes (1)

• Placental perfusion fraction (f) measured by IVIM-DWI

  Two years

Study Arms (2)

Pregnant women with gestational diabetes mellitus

EXPERIMENTAL

3Th trimester pregnant women with gestational diabetes mellitus

Diagnostic Test: DW-MRI

Low risk pregnant women

ACTIVE COMPARATOR

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

Diagnostic Test: DW-MRI

Interventions

DW-MRI DIAGNOSTIC_TEST

Predict changes in ovarian diffusion using DW-MRI scan

Low risk pregnant women; Pregnant women with gestational diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Pregnancy in Diabetics; Placenta Diseases

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rinat Gabbay-Benziv, Prof

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinat Gabbay-Benziv, Prof

CONTACT

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

Moran Rotman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: May 28, 2025
• Study Start: July 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

IL (1)