Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
December 9, 2016 updated by: Shanghai First Maternity and Infant Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
144
Phase
- Not Applicable
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Cases corresponding to diagnosis standards
- Willing to accept the regular follow-up
Exclusion Criteria:
- Immune hydrops fetalis
- Multiple pregnancy, except for twin-to-twin transfusion syndrome IV
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: exposure group
subjects in this group are those who accept intrauterine intervention
|
choose different surgeries according to different causes
|
|
No Intervention: control group
subjects in this group are those who do not accept intrauterine intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neonatal mortality
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Success rate for the operation
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
December 1, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 3, 2016
First Posted (Estimate)
November 6, 2016
Study Record Updates
Last Update Posted (Estimate)
December 12, 2016
Last Update Submitted That Met QC Criteria
December 9, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShanghaiFMIH-FMU1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.