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Characterization of Placental Diffusion

NCT ID: NCT06992245

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Pregnancy in Diabetic Placenta Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The 2 arms will include 3th trimester pregnant women. Group 1- diabetic pregnant women Group 2- low risk pregnant women
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pregnant women with gestational diabetes mellitus

3Th trimester pregnant women with gestational diabetes mellitus

Group Type EXPERIMENTAL

DW-MRI

Intervention Type DIAGNOSTIC_TEST

Predict changes in ovarian diffusion using DW-MRI scan

Low risk pregnant women

3Th trimester pregnant women with unknown diseases (low risk factors)

Group Type ACTIVE_COMPARATOR

DW-MRI

Intervention Type DIAGNOSTIC_TEST

Predict changes in ovarian diffusion using DW-MRI scan

Interventions

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DW-MRI

Predict changes in ovarian diffusion using DW-MRI scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rinat Gabbay-Benziv, Prof

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hille Yaffe Medical Center

Hadera, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Rinat Gabbay-Benziv, Prof

Role: CONTACT

Phone: +972-4-7744514

Email: [email protected]

Moran Rotman, MD

Role: CONTACT

Phone: +972-4-7744514

Email: [email protected]

Facility Contacts

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Osnat Palgi Mirochnik, Bsc, RN

Role: primary

Other Identifiers

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0042-22-HYMC

Identifier Type: -

Identifier Source: org_study_id