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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