Pregnancy in DiabeticNCT06992245
Characterization of Placental Diffusion
A study testing DW-MRI in people with Pregnancy in Diabetic and Placenta Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetic, Placenta Diseases
- What is being tested?
- DW-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Center
Hadera, 38100
Osnat Palgi Mirochnik, Bsc, RN, +974-47744602, osnatp@hymc.gov.il
About this study
Official title: Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI
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.
Read the 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.
- Conditions
- Pregnancy in Diabetic, Placenta Diseases
- Being tested
- DW-MRI
- Medical subject headings
- Pregnancy in Diabetics, Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-MRIDiagnostic test
Predict changes in ovarian diffusion using DW-MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with gestational diabetes mellitus | Experimental | 3Th trimester pregnant women with gestational diabetes mellitus Receives: Diagnostic Test: DW-MRI |
| Low risk pregnant women | Active comparator | 3Th trimester pregnant women with unknown diseases (low risk factors) Receives: Diagnostic Test: DW-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (1)
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start6 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The 2 arms will include 3th trimester pregnant women. Group 1- diabetic pregnant women Group 2- low risk pregnant women
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, Prof, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992245
- Sponsor's protocol ID
- 0042-22-HYMC
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Placental Diffusion in Women With Diabetes Using DW-MRI
- ClinicalTrials.gov ID
- NCT06992245
- Acronym / sponsor ID
- 0042-22-HYMC
- Conditions
- Pregnancy in Diabetic, Placenta Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The 2 arms will include 3th trimester pregnant women. Group 1- diabetic pregnant women Group 2- low risk pregnant women
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with gestational diabetes mellitus | Experimental | Diagnostic Test: DW-MRI3Th trimester pregnant women with gestational diabetes mellitus |
| Low risk pregnant women | Active comparator | Diagnostic Test: DW-MRI3Th trimester pregnant women with unknown diseases (low risk factors) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DW-MRIPredict changes in ovarian diffusion using DW-MRI scan | Diagnostic test | Low risk pregnant women, Pregnant women with gestational diabetes mellitus |
Primary outcome
Placental diffusion coefficient (D) measured by IVIM-DWI
Time frame: Two years
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.
1 secondary outcome
Placental perfusion fraction (f) measured by IVIM-DWI
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rinat Gabbay-Benziv, Prof principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DW-MRI in people with Pregnancy in Diabetic and Placenta Diseases, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rinat Gabbay-Benziv, Prof (+972-4-7744514, rinatg@hymc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental diffusion coefficient (D) measured by IVIM-DWI (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.