Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Primary Purpose
Fetal Hydrops
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intrauterine intervention
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Hydrops
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
exposure group
control group
Arm Description
subjects in this group are those who accept intrauterine intervention
subjects in this group are those who do not accept intrauterine intervention
Outcomes
Primary Outcome Measures
Neonatal mortality
Secondary Outcome Measures
Success rate for the operation
Full Information
NCT ID
NCT02956564
First Posted
November 2, 2016
Last Updated
December 9, 2016
Sponsor
Shanghai First Maternity and Infant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02956564
Brief Title
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Official Title
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Hydrops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exposure group
Arm Type
Other
Arm Description
subjects in this group are those who accept intrauterine intervention
Arm Title
control group
Arm Type
No Intervention
Arm Description
subjects in this group are those who do not accept intrauterine intervention
Intervention Type
Procedure
Intervention Name(s)
intrauterine intervention
Intervention Description
choose different surgeries according to different causes
Primary Outcome Measure Information:
Title
Neonatal mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Success rate for the operation
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
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