Diffusion Weighted Magnetic Resonance Imaging of Brain in Monochorionic Twin Pregnancies With Demise of One Fetus

July 14, 2021 updated by: Peking University Third Hospital
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. In this study, conventional and diffusion-weighted MRI (DWI, DTI) sequences were used to analyze the brain of monochorionic twin pregnancies with demise of one fetus.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Twin pregnancy was diagnosed and one fetus died in utero
  2. Twin pregnancy with one abnormal fetus
  3. Singleton pregnancy with abnormalities outside the fetal brain

Description

Inclusion Criteria:

  1. Twin pregnancy was diagnosed and one fetus died in utero
  2. Twin pregnancy with one abnormal fetus
  3. Singleton pregnancy with abnormalities outside the fetal brain

Exclusion Criteria:

  1. Those who can't cooperate with MRI examination, such as those who have metal, claustrophobia or can't insist on scanning.
  2. Pregnant women with gestational age less than 20 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ying Liu, Dr., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

June 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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