Chromosome AbnormalityNCT02982356
Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
A study testing Fetal Selective Reduction Technology and Potassium Chloride in people with Chromosome Abnormality and Twin Pregnancy With Antenatal Problem, run by Shanghai First Maternity and Infant Hospital.
Trial summary
The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chromosome Abnormality, Twin Pregnancy With Antenatal Problem
- What is being tested?
- Fetal Selective Reduction Technology and Potassium Chloride
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ultrasound diagnosis as twin pregnancy
- at 11-14 gestational weeks
Who cannot join
- Multiple pregnancies (three or more)
- Maternal history of chromosome aneuploidy abnormality or tumor
About this study
The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies:
- to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.
- fetal chromosomal abnormalities
- Being tested
- Fetal Selective Reduction Technology, Potassium Chloride
- Medical subject headings
- Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Selective Reduction TechnologyProcedure or surgery
Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks
Potassium ChlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Fetal Selective Reduction Technology | Other | Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure Receives: Procedure: Fetal Selective Reduction Technology; Drug: Potassium Chloride |
| control group | No intervention | normal dichorial twins without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate for the operation
Measured: 1 week
Secondary outcomes (1)
long-term complications after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosome AbnormalityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982356
- Sponsor's protocol ID
- ShanghaiFMIH-FMU2
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The Individual Participant Data sharing plan will be discussed with the other collaborators
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
- ClinicalTrials.gov ID
- NCT02982356
- Acronym / sponsor ID
- ShanghaiFMIH-FMU2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- 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.
The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies:
- to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.
- fetal chromosomal abnormalities
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal Selective Reduction Technology | Other | Procedure: Fetal Selective Reduction Technology, Drug: Potassium ChloridePotassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure |
| control group | No intervention | –normal dichorial twins without any intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ultrasound diagnosis as twin pregnancy
- at 11-14 gestational weeks
Key exclusion criteria (2 listed)
- Multiple pregnancies (three or more)
- Maternal history of chromosome aneuploidy abnormality or tumor
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 |
|---|---|---|
| Fetal Selective Reduction TechnologyFetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks | Procedure or surgery | Fetal Selective Reduction Technology |
| Potassium Chloride | Drug | Fetal Selective Reduction Technology |
Primary outcome
Success rate for the operation
Time frame: 1 week
1 secondary outcome
long-term complications after surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Individual participant dataSharing planned: Undecided. The Individual Participant Data sharing plan will be discussed with the other collaborators
Related trials for Chromosome Abnormality
RecruitingPhase 3
BEACON - Phase III Clinical Study of Rugonersen in Angelman Syndrome.
Angelman Syndrome
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Selective Reduction Technology and Potassium Chloride in people with Chromosome Abnormality and Twin Pregnancy With Antenatal Problem, run by Shanghai First Maternity and Infant Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Success rate for the operation (time frame: 1 week). 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 Dec 2016.