Fetal HydropsNCT02956564
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
A study testing intrauterine intervention in people with Fetal Hydrops, run by Shanghai First Maternity and Infant Hospital.
Trial summary
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Hydrops
- What is being tested?
- intrauterine intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Aug 2018
- 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
- Cases corresponding to diagnosis standards
- Willing to accept the regular follow-up
Who cannot join
- Immune hydrops fetalis
- Multiple pregnancy, except for twin-to-twin transfusion syndrome IV
About this study
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.
Read the detailed description
- Etiological study of Non-immune fetal hydrops(NIFH):
- Etiological study of NIFH in mid-pregnancy period;
- Etiological study of NIFH and hygroma colli in first trimester;
- Value assessment of technology for exome sequencing in diagnosis of NIFH;
- The accuracy of NIFH intrauterine intervention and its effect assessment:
- Perinatal outcomes of NIFH ;
- The effect of intrauterine treatments.
- Conditions
- Fetal Hydrops
- Being tested
- intrauterine intervention
- Medical subject headings
- Hydrops Fetalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrauterine interventionProcedure or surgery
choose different surgeries according to different causes
| Study group | Role | What they receive |
|---|---|---|
| exposure group | Other | subjects in this group are those who accept intrauterine intervention Receives: Procedure: intrauterine intervention |
| control group | No intervention | subjects in this group are those who do not accept intrauterine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality
Measured: 1 year
Secondary outcomes (1)
Success rate for the operation
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HydropsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956564
- Sponsor's protocol ID
- ShanghaiFMIH-FMU1
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
- ClinicalTrials.gov ID
- NCT02956564
- Acronym / sponsor ID
- ShanghaiFMIH-FMU1
- Conditions
- Fetal Hydrops
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 7 Nov 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.
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.
Detailed description
- Etiological study of Non-immune fetal hydrops(NIFH):
- Etiological study of NIFH in mid-pregnancy period;
- Etiological study of NIFH and hygroma colli in first trimester;
- Value assessment of technology for exome sequencing in diagnosis of NIFH;
- The accuracy of NIFH intrauterine intervention and its effect assessment:
- Perinatal outcomes of NIFH ;
- The effect of intrauterine treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure group | Other | Procedure: intrauterine interventionsubjects in this group are those who accept intrauterine intervention |
| control group | No intervention | –subjects in this group are those who do not accept intrauterine intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cases corresponding to diagnosis standards
- Willing to accept the regular follow-up
Key exclusion criteria (2 listed)
- Immune hydrops fetalis
- Multiple pregnancy, except for twin-to-twin transfusion syndrome IV
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 |
|---|---|---|
| intrauterine interventionchoose different surgeries according to different causes | Procedure or surgery | exposure group |
Primary outcome
Neonatal mortality
Time frame: 1 year
1 secondary outcome
Success rate for the operation
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Hydrops
Active, not recruiting
Hydrops: Diagnosing & Redefining Outcomes With Precision Study
Hydrops Fetalis, Birth Defect
Enrolling by invitation
Uncovering the Etiologies of Non-immune Hydrops Fetalis
Non-Immune Hydrops Fetalis
RecruitingObservational study
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease
Recruiting
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
Haemoglobin Barts Hydrops
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 intrauterine intervention in people with Fetal Hydrops, 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 12 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?
Neonatal mortality (time frame: 1 year). 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 12 Dec 2016.