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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
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Hydrops

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    November 2, 2016
    Last Updated
    December 9, 2016
    Sponsor
    Shanghai First Maternity and Infant Hospital
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    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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