Characterization of Placental Diffusion

ConditionsPregnancy in Diabetic Placenta Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorHillel Yaffe Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Pregnant women with gestational diabetes mellitusExperimental treatment 1 intervention

Group B: Low risk pregnant womenActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Two years

Secondary outcomes

Placental perfusion fraction (f) measured by IVIM-DWI

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

Time frame

Two years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hillel Yaffe Medical Center

Lead sponsor

Source ClinicalTrials.gov

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