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NCT Number: NCT06992245

Characterization of Placental Diffusion

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.

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Key information

Conditions

Pregnancy in Diabetic Female Urogenital Diseases and Pregnancy Complications Placenta Diseases Pregnancy Complications Pregnancy in Diabetics Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location status: Recruiting

Location contact

Osnat Palgi Mirochnik, Bsc, RN

CONTACT

[email protected]

+974-47744602

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW-MRI

Diagnostic Test

Predict changes in ovarian diffusion using DW-MRI scan

Primary outcomes

  1. Placental diffusion coefficient (D) measured by IVIM-DWI

    Time frame: Two years

    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.

Secondary outcomes

  1. Placental perfusion fraction (f) measured by IVIM-DWI

    Time frame: Two years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Moran Rotman, MD

CONTACT

[email protected]

+972-4-7744514

Rinat Gabbay-Benziv, Prof

CONTACT

[email protected]

+972-4-7744514

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 28, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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