Twin Pregnancy With Antenatal ProblemNCT04966039
Diffusion Weighted Magnetic Resonance Imaging of Brain in Monochorionic Twin Pregnancies With Demise of One Fetus
An observational study of Twin Pregnancy With Antenatal Problem, run by Peking University Third Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Child, Adult, Older adult
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
Who may be able to join
- Twin pregnancy was diagnosed and one fetus died in utero
- Twin pregnancy with one abnormal fetus
- Singleton pregnancy with abnormalities outside the fetal brain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Twin Pregnancy With Antenatal Problem
- Being tested
- No intervention.
- Keywords
- twin pregnancy, demise of one fetus, Diffusion weighted imaging, Diffusion tensor imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
There was no intervention.
| Study group | Role | What they receive |
|---|---|---|
| monochorionic twin pregnancies with demise of one fetus | Twin pregnancy was diagnosed and one fetus died in utero, 20 pregnant women Receives: Other: No intervention. | |
| Twin control group | Twin pregnancy with one abnormal fetus, 20 pregnant women Receives: Other: No intervention. | |
| Singleton control group | Singleton pregnancy with abnormalities outside the fetal brain, 20 pregnant women Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
basic information
age
Measured: baseline
basic information
gestational age
Measured: baseline
basic information
uterine height
Measured: baseline
basic information
abdominal circumference
Measured: baseline
basic information
intrauterine death time of one fetus
Measured: baseline
MRI
DWI sequence (ADC value)
Measured: baseline
MRI
DTI sequence (FA value)
Measured: baseline
MRI
conventional sequence
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Liu, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966039
- Sponsor's protocol ID
- M2017316
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted Magnetic Resonance Imaging of Brain in Monochorionic Twin Pregnancies With Demise of One Fetus
- ClinicalTrials.gov ID
- NCT04966039
- Acronym / sponsor ID
- M2017316
- Conditions
- Twin Pregnancy With Antenatal Problem
- Keywords
- twin pregnancy, demise of one fetus, Diffusion weighted imaging, Diffusion tensor imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jul 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| monochorionic twin pregnancies with demise of one fetus | – | Other: No intervention.Twin pregnancy was diagnosed and one fetus died in utero, 20 pregnant women |
| Twin control group | – | Other: No intervention.Twin pregnancy with one abnormal fetus, 20 pregnant women |
| Singleton control group | – | Other: No intervention.Singleton pregnancy with abnormalities outside the fetal brain, 20 pregnant women |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Twin pregnancy was diagnosed and one fetus died in utero
- Twin pregnancy with one abnormal fetus
- Singleton pregnancy with abnormalities outside the fetal brain
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| No intervention.There was no intervention. | Other | Singleton control group, Twin control group, monochorionic twin pregnancies with demise of one fetus |
Primary outcome
basic information
Time frame: baseline
age
basic information
Time frame: baseline
gestational age
basic information
Time frame: baseline
uterine height
basic information
Time frame: baseline
abdominal circumference
basic information
Time frame: baseline
intrauterine death time of one fetus
MRI
Time frame: baseline
DWI sequence (ADC value)
MRI
Time frame: baseline
DTI sequence (FA value)
MRI
Time frame: baseline
conventional sequence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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RecruitingObservational study
Twin Pregnancy: a Challenge for Patients, Families and Health Professionals
Twin Pregnancy With Antenatal Problem, Twin Diseases
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. This study is not recruiting at the moment.
Ying Liu, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy With Antenatal Problem, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jul 2021. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basic information (time frame: baseline). The study lists 8 primary outcomes in all. 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 19 Jul 2021.