Twin DiseasesNCT03650985
Diagnosis and Intervention of Complicated Twin Diseases
A study testing Fetoscope technique in people with Twin Diseases, run by Shengjing Hospital at 1 site in China.
Trial summary
Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established , but they are still needed to be improved. 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
- Twin Diseases
- What is being tested?
- Fetoscope technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2018to Aug 2022
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.
Who cannot join
- Pregnancy women who refuse intrauterine treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital
Shenyang, Liaoning
Shaowei Yin, PhD, 86-18902458403, yinsw1984@163.com
Shaojiang Liu, 86-18002454803, liushaojiang@qq.com
About this study
Official title: Diagnosis and Intervention of Complicated Twin Diseases in China
Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established , but they are still needed to be improved. Through this study, the investigators expect to achieve better prediction indicators and early intrauterine precise diagnosis of complicated twin diseases. Also, better procedures of implementing effective intrauterine intervention and assessing the safety and effectiveness of intrauterine intervention are anticipated to be established.
Read the detailed description
A better guideline for complicated twin diseases are anticipated to be established in China. Molecular genetics and imaging technology are applied to evaluate the outcome and prognosis of intrauterine intervention for complex twin diseases. 3D printing technology is used to assist the preoperative evaluation of fetal intrauterine intervention. Better fetal intrauterine intervention technique and prognosis evaluation are expected to be established.
- Conditions
- Twin Diseases
- Being tested
- Fetoscope technique
- Medical subject headings
- Diseases in Twins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscope techniqueProcedure or surgery
Intrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients.
| Study group | Role | What they receive |
|---|---|---|
| TOCTD | Experimental | Pregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent, will be involved. Fetoscope technique will be administered in suitable patients. Receives: Procedure: Fetoscope technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression of fetuses
DNA methylation, histone acetylation etc. assessed by analyses of fetal blood and amniotic fluid.
Measured: At 20 week of gestational age
Change of volume of amniotic fluid in Milliliter
Measured by doctors of sonography
Measured: At every two week from the sixteenth week of gestational age to delivery of babies
Change of umbilical artery blood flow
Measured by doctors of sonography
Measured: At every two week from the sixteenth week of gestational age to delivery of babies
Secondary outcomes (1)
Neurodevelopment at early childhood
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.
Measured: At age of 1 year old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start31 Aug 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin DiseasesStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caixia Liu, Shengjing Hospital
- Investigators
- Caixia Liu, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650985
- Sponsor's protocol ID
- DICTD
- Status last verified
- Sep 2018
- First submitted
- 27 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Intervention of Complicated Twin Diseases in China
- ClinicalTrials.gov ID
- NCT03650985
- Acronym / sponsor ID
- DICTD
- Conditions
- Twin Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 29 Aug 2018 (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.
Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established , but they are still needed to be improved. Through this study, the investigators expect to achieve better prediction indicators and early intrauterine precise diagnosis of complicated twin diseases. Also, better procedures of implementing effective intrauterine intervention and assessing the safety and effectiveness of intrauterine intervention are anticipated to be established.
Detailed description
A better guideline for complicated twin diseases are anticipated to be established in China. Molecular genetics and imaging technology are applied to evaluate the outcome and prognosis of intrauterine intervention for complex twin diseases. 3D printing technology is used to assist the preoperative evaluation of fetal intrauterine intervention. Better fetal intrauterine intervention technique and prognosis evaluation are expected to be established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent.
| Arm | Type | Receives |
|---|---|---|
| TOCTD | Experimental | Procedure: Fetoscope techniquePregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent, will be involved. Fetoscope technique will be administered in suitable patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.
Key exclusion criteria (1 listed)
- Pregnancy women who refuse intrauterine treatment.
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 |
|---|---|---|
| Fetoscope techniqueIntrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients. | Procedure or surgery | TOCTD |
Primary outcome
Gene expression of fetuses
Time frame: At 20 week of gestational age
DNA methylation, histone acetylation etc. assessed by analyses of fetal blood and amniotic fluid.
Change of volume of amniotic fluid in Milliliter
Time frame: At every two week from the sixteenth week of gestational age to delivery of babies
Measured by doctors of sonography
Change of umbilical artery blood flow
Time frame: At every two week from the sixteenth week of gestational age to delivery of babies
Measured by doctors of sonography
1 secondary outcome
Neurodevelopment at early childhood
Time frame: At age of 1 year old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Caixia Liu principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscope technique in people with Twin Diseases, run by Shengjing 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caixia Liu (86-18902451716, liucx1716@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression of fetuses (time frame: At 20 week of gestational age). The study lists 3 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 5 Sep 2018.