Characterization of Placental Diffusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DW-MRI.
- Who it may be relevant to
- Registry conditions: Pregnancy in Diabetic, Placenta Diseases. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI
Overview
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.
Interventions
- Diagnostic test DW-MRI
Predict changes in ovarian diffusion using DW-MRI scan
Primary outcome measures
- Placental diffusion coefficient (D) measured by IVIM-DWI [Time frame: Two years]
Secondary outcome measures (1)
- Placental perfusion fraction (f) measured by IVIM-DWI [Time frame: Two years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Israel · 1 center
- Hille Yaffe Medical Center — Hadera
Identifiers
NCT: NCT06992245 · 0042-22-HYMC