- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04966039
Diffusion Weighted Magnetic Resonance Imaging of Brain in Monochorionic Twin Pregnancies With Demise of One Fetus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With the incidence rate of twin pregnancy increasing, the incidence of intrauterine death of twin pregnancies is also rising, which has great impact on the morbidity and mortality of the other fetus, and increases the mortality of fetal survival, premature birth, brain damage and long-term sequela. Therefore, it is necessary to examine the central nervous system of the surviving fetus of twin pregnancy and intrauterine death. When the surviving fetus is complicated with nervous system abnormalities, conventional MRI can generally make a diagnosis. However, some of the surviving fetuses may not find other structural or echo abnormalities on B-mode ultrasonography, and even these fetuses do not find structural or signal abnormalities on routine MRI examination. Whether the surviving fetuses may have brain abnormalities cannot be detected early by the above methods. Diffusion weighted imaging (DWI) can reflect the microstructure and pathological changes of tissue, and diffusion tensor imaging (DTI) can quantitatively evaluate the fine structure of white matter in brain.
The present study is to use conventional sequence and diffusion-weighted imaging (DWI, DTI) to analyze the brain of monochorionic twin pregnancies with demise of one fetus, which aims to find the potential brain abnormalities early and provide some guidance for the clinical diagnosis and treatment in the next step.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Beijing, China
- Peking University Third Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Twin pregnancy was diagnosed and one fetus died in utero
- Twin pregnancy with one abnormal fetus
- Singleton pregnancy with abnormalities outside the fetal brain
Description
Inclusion Criteria:
- Twin pregnancy was diagnosed and one fetus died in utero
- Twin pregnancy with one abnormal fetus
- Singleton pregnancy with abnormalities outside the fetal brain
Exclusion Criteria:
- Those who can't cooperate with MRI examination, such as those who have metal, claustrophobia or can't insist on scanning.
- Pregnant women with gestational age less than 20 weeks.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
monochorionic twin pregnancies with demise of one fetus
Twin pregnancy was diagnosed and one fetus died in utero, 20 pregnant women
|
There was no intervention.
|
|
Twin control group
Twin pregnancy with one abnormal fetus, 20 pregnant women
|
There was no intervention.
|
|
Singleton control group
Singleton pregnancy with abnormalities outside the fetal brain, 20 pregnant women
|
There was no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
basic information
Time Frame: baseline
|
age
|
baseline
|
|
basic information
Time Frame: baseline
|
gestational age
|
baseline
|
|
basic information
Time Frame: baseline
|
uterine height
|
baseline
|
|
basic information
Time Frame: baseline
|
abdominal circumference
|
baseline
|
|
basic information
Time Frame: baseline
|
intrauterine death time of one fetus
|
baseline
|
|
MRI
Time Frame: baseline
|
DWI sequence (ADC value)
|
baseline
|
|
MRI
Time Frame: baseline
|
DTI sequence (FA value)
|
baseline
|
|
MRI
Time Frame: baseline
|
conventional sequence
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ying Liu, Dr., Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2017316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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