Comparing placental diffusion in diabetic and healthy pregnant women
Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI
This study is testing if using special MRI scans can help understand how the placenta works in pregnant women with uncontrolled diabetes compared to healthy pregnant women, to see if it affects the baby’s oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Hillel Yaffe Medical Center Government |
| Locations | 1 site (Hadera) |
| Trial ID | NCT06992245 on ClinicalTrials.gov |
What this trial studies
This study uses diffusion-weighted MRI (DW-MRI) to assess and compare placental diffusion in pregnant women with uncontrolled diabetes against healthy pregnant women. The goal is to investigate the relationship between placental diffusion and potential fetal hypoxia, which may contribute to fetal death. By identifying changes in placental diffusion, the researchers hope to uncover mechanisms behind fetal damage and develop predictive protocols for at-risk pregnancies.
Who should consider this trial
Good fit: Ideal candidates include pregnant women diagnosed with pre-gestational or gestational diabetes.
Not a fit: Patients with a history of placental hypoxia disease or those in active labor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and prediction of fetal risks in pregnancies complicated by diabetes.
How similar studies have performed: While the approach of using DW-MRI for placental assessment is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hadera
- Hille Yaffe Medical Center — Hadera, Israel (Recruiting)
Study contacts
- Principal investigator: Rinat Gabbay-Benziv, Prof — Hillel Yaffe Medical Center
- Study coordinator: Rinat Gabbay-Benziv, Prof
- Email: rinatg@hymc.gov.il
- Phone: +972-4-7744514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.