Characterization of Placental Diffusion

NCT06992245 — Not applicable, Recruiting, 40 participants, Hillel Yaffe Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06992245
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, diagnostic
Enrollment	40 (Estimated)
Sponsor	Hillel Yaffe Medical Center (Other gov)
Conditions	Pregnancy in Diabetic, Placenta Diseases
Interventions	DW-MRI (Diagnostic test)
Dates	start 2023-07-06, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-05-28, last updated 2025-12-24
Locations	1 site in Israel

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Pregnant women with gestational diabetes mellitus	Experimental	Diagnostic Test: DW-MRI	3Th trimester pregnant women with gestational diabetes mellitus
Low risk pregnant women	Active comparator	Diagnostic Test: DW-MRI	3Th trimester pregnant women with unknown diseases (low risk factors)

DW-MRI (Diagnostic test): Predict changes in ovarian diffusion using DW-MRI scan

+Outcome measures

Primary outcomes

Placental diffusion coefficient (D) measured by IVIM-DWI [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

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

+Eligibility

Sex: Female, ages: 18 Years to 50 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Hille Yaffe Medical Center	Hadera	Israel	Recruiting

+Investigators

Rinat Gabbay-Benziv, Prof, Principal investigator, Hillel Yaffe Medical Center