Characterization of Placental Diffusion

Hillel Yaffe Medical Center

Status: Enrolling

Conditions: Pregnancy in Diabetic; Placenta Diseases

Treatments: Diagnostic Test: DW-MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06992245

0042-22-HYMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Pregnant women with gestational diabetes mellitus

Experimental group

Description:

3Th trimester pregnant women with gestational diabetes mellitus

Treatment:

Diagnostic Test: DW-MRI

Low risk pregnant women

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: DW-MRI