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

NCT ID: NCT02956564

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Fetal Hydrops

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exposure group

subjects in this group are those who accept intrauterine intervention

Group Type OTHER

intrauterine intervention

Intervention Type PROCEDURE

choose different surgeries according to different causes

control group

subjects in this group are those who do not accept intrauterine intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intrauterine intervention

choose different surgeries according to different causes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ShanghaiFMIH-FMU1

Identifier Type: -

Identifier Source: org_study_id