Characterization of Placental Diffusion

Not Applicable

Recruiting

• Conditions: Pregnancy in Diabetic; Placenta Diseases

• Registration Number: NCT06992245
• Lead Sponsor: Hillel Yaffe Medical Center

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.

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 Timeline

• Study First Submitted: 2022-12-05
• Study Start: 2023-07-06
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IVIM-DWI-based placental functional assessment from research DWI data.	Two years	IVIM model parameters (D (mm\^2/s),D\* (mm\^2/s),f (fraction \[0,1\]) will be calculate using standard approaches (i.e. non-linear least squares) and using physically-primed DNN models.; The investigators will determine differences in the IVIM model parameters calculated with the the physically-primed DNN models between the two groups using standard statistical tests (i.e Student's t-test in case of normally distributed data, or Mann-Whitney U Test in case of non-normally-distributed data).

Secondary Outcome Measures

Name	Time	Method
Significance of the groups differences for each parameter	Two years	The investigators will compare the significance of the groups differences for each parameter of the IVIM parameters (p-values) to determine which parameter is mostly associated with the difference between groups.

Trial Locations

Locations (1)

Hille Yaffe Medical Center; 🇮🇱 Hadera, Israel