Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06992245

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

Led by Hillel Yaffe Medical Center · Updated on 2025-12-24

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating placental diffusion changes in pregnant women with uncontrolled diabetes compared to healthy pregnant women. The study aims to understand how tissue hypoxia in the placenta may contribute to fetal damage and the risk of intrauterine fetal death, which is more common in cases of poorly controlled diabetes. This research hopes to develop methods to predict pregnancies at risk of fetal death using advanced imaging techniques. The study uses diffusion-weighted magnetic resonance imaging (DW-MRI) to measure placental diffusion and perfusion. Two groups of third-trimester pregnant women participate: those with gestational diabetes mellitus and those considered low risk without known diseases. The DW-MRI scans are used to quantitatively compare placental diffusion between these groups over a two-year period. Participants will undergo DW-MRI scans to assess placental diffusion coefficient and perfusion fraction. Researchers will monitor and compare these measures between diabetic and healthy pregnancies. The primary outcome is the placental diffusion coefficient measured by intravoxel incoherent motion diffusion-weighted imaging (IVIM-DWI), with the secondary outcome being placental perfusion fraction. The study includes pregnant women aged 18 to 50 years and follows them to better understand placental changes related to diabetes during pregnancy.

CONDITIONS

Brief Title

Characterization of Placental Diffusion

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with pre-gestational diabetes diagnosed before 20 weeks of pregnancy
  • Women with gestational diabetes diagnosed by oral glucose tolerance test after 20 weeks of pregnancy
  • Female participants
  • Pregnant with a single fetus
  • Age between 18 and 50 years
Not Eligible

You will not qualify if you...

  • Pregnant women with placental hypoxia disease in the past
  • Pregnant women with current placental hypoxia disease
  • Multiple pregnancy (twins or more)
  • Women in active labor or with rupture of membranes
  • Women who smoke
  • Suspicion of placenta accreta

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single session during the 3rd trimester

Participants undergo DW-MRI scans to assess placental diffusion and perfusion characteristics.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are observed for up to two years to evaluate placental diffusion coefficients and perfusion fractions over time.

Follow-up visits as scheduled over two years

Trial Site Locations

Total: 1 location

1

Hille Yaffe Medical Center

Hadera, Israel, 38100

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Research Team

R

Rinat Gabbay-Benziv, Prof

M

Moran Rotman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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