Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Overview
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 Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2018
Detailed Description
1. Etiological study of Non-immune fetal hydrops(NIFH): 1. Etiological study of NIFH in mid-pregnancy period; 2. Etiological study of NIFH and hygroma colli in first trimester; 3. Value assessment of technology for exome sequencing in diagnosis of NIFH; 2. The accuracy of NIFH intrauterine intervention and its effect assessment: 1. Perinatal outcomes of NIFH ; 2. The effect of intrauterine treatments.
Interventions
- Procedure: intrauterine intervention
- choose different surgeries according to different causes
Arms, Groups and Cohorts
- Other: exposure group
- subjects in this group are those who accept intrauterine intervention
- No Intervention: control group
- subjects in this group are those who do not accept intrauterine intervention
Clinical Trial Outcome Measures
Primary Measures
- Neonatal mortality
- Time Frame: 1 year
Secondary Measures
- Success rate for the operation
- Time Frame: 1 week
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Shanghai First Maternity and Infant Hospital
- Provider of Information About this Clinical Study
- Sponsor
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