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Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment

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ClinicalTrials.gov Identifier: NCT02956564
Recruitment Status : Unknown
Verified November 2016 by Shanghai First Maternity and Infant Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 7, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

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.

Condition or disease Intervention/treatment Phase
Fetal Hydrops Procedure: intrauterine intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
exposure group
subjects in this group are those who accept intrauterine intervention
Procedure: 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



Primary Outcome Measures :
  1. Neonatal mortality [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Success rate for the operation [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT02956564     History of Changes
Other Study ID Numbers: ShanghaiFMIH-FMU1
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hydrops Fetalis
Edema
Signs and Symptoms
Erythroblastosis, Fetal
Fetal Diseases
Pregnancy Complications
Hematologic Diseases
alpha-Thalassemia
Thalassemia
Hemoglobinopathies
Genetic Diseases, Inborn
Immune System Diseases